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COOK INC BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
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| Catalog Number 025227-OE |
| Device Problems
Migration or Expulsion of Device (1395); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Respiratory Failure (2484); No Information (3190)
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| Event Date 08/30/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
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Event Description
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The user facility reported in email correspondence they have had a few serious incidents where the patient has been affected by the bander ureteral diversion stent set.There is an internal investigation in process.This issue has occurred on at least 3 separate occasions.Requests have been made for additional patient, device and event details.This customer reported at least three (3) incidents.These incidents have been captured in three separate medwatch reports.Please see related mfr.Report numbers 1820334-2017-03243, 1820334-2017-03244 and 1820334-2017-03245.
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Manufacturer Narrative
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Additional information received: description of event.Relevant tests/lab data.Preexisting conditions.Updated fields based on additional information received: patient codes & device codes.Patient code: respiratory failure; not labeled, infection; not labeled, organs(s), perforation of; not labeled.Device code: migration of device or device component; not labeled.Investigation ¿ evaluation: the complaint device was not returned for evaluation and no photographs or imaging was provided.Without the complaint device, a physical investigation was not able to be completed.A document-based investigation/evaluation was performed.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was conducted.A review of the device history records for the complaint device lot number 7097889 revealed there were no non-conformances related to the complaint issue.A search of the complaints database for additional complaints referencing lot 7097889 revealed one additional complaint from the same user facility.This complaint was previously reported in related manufacturer report # 1820334-2017-03243.(b)(4).As found in the instructions for use (ifu), precautions section: manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using a wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.The included wire guide is not intended for ptca use.Hydrophilically coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The root cause cannot be confirmed for the complaint issue, however as final stent placement is under user control; user technique is indicated.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It was reported that on (b)(6) 2017, a 67-year-old male patient with bladder cancer had a radical cystoprostatectomy, bilateral lymph node dissection and formation of ileal conduit performed using the bander ureteral open end stent set.As reported, nothing was noted immediately.On (b)(6) 2017, post-operatively, the patient went into respiratory failure and was admitted to the intensive care unit (itu) also with infection.Patient was intubated and managed for acute respiratory distress syndrome and given large doses inotropes.(b)(6) 2017, computerized tomography (ct) scan showed ascites in his abdomen (no drainable collection) and patient was still in respiratory failure.Patient remained unwell "chest wise" and raised inflammatory markers - rescanned.(b)(6) 2017, collection in right iliac fossa (rif) has increased in size.Now has increased attenuation suggestive of hemorrhage.No active extravasation.Not in either report but noticed on imaging, stent has perforated kidney.The stent had gone through the cortex of the kidney.(b)(6) 2017, the stent was pulled back while in the intensive care unit.(b)(6) 2017, bilateral nephrostomies performed using two pigtail drains.The bander stent was removed.An anastomotic leak was noted but advised this was not from the previous stented kidney.(b)(6) 2017, failed extubation, mucous plug.Multpile antibiotics and antifungals used for chest infection and respiratory complications.Remains in itu with "chest".Nephrosotomies in place for anastomotic leak currently and abdominal drain.Anastomotic breakdown likely due to inotropes to support chest sepsis.As reported, no long-term complications or sequale from stent expected.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information received: date of event.Description of event.Relevant tests/lab data.Preexisting conditions.Updated fields based on additional information received: patient codes & device codes.Patient code: pain; not labeled, organs(s).Device code: migration of device or device component; not labeled.The complaint device was not returned for evaluation and no photographs or imaging was provided.Without the complaint device, a physical investigation was not able to be completed.A document-based investigation/evaluation was performed.A review of the instructions for use, quality control data, and specifications was conducted.A review of the device history records for the complaint device could not be performed as the lot number of the complaint device was not provided.A search of the complaints database for additional complaints associated with the complaint device lot number could not be completed without the lot number.As found in the instructions for use (ifu), precautions section: manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using a wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.The included wire guide is not intended for ptca use.Hydrophilically coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The root cause cannot be confirmed for the complaint issue, however as final stent placement is under user control; user technique is indicated.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.H3 other text : blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information received: date of event.Description of event.Relevant tests/lab data.Preexisting conditions.Updated fields based on additional information received: patient codes & device codes.Patient code: pain; not labeled, organs(s).Device code: migration of device or device component; not labeled.The complaint device was not returned for evaluation and no photographs or imaging was provided.Without the complaint device, a physical investigation was not able to be completed.A document-based investigation/evaluation was performed.A review of the instructions for use, quality control data, and specifications was conducted.A review of the device history records for the complaint device could not be performed as the lot number of the complaint device was not provided.A search of the complaints database for additional complaints associated with the complaint device lot number could not be completed without the lot number.As found in the instructions for use (ifu), precautions section: manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using a wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.The included wire guide is not intended for ptca use.Hydrophilically coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The root cause cannot be confirmed for the complaint issue, however as final stent placement is under user control; user technique is indicated.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It was reported a 71-year-old female patient with endometrial cancer, vaginal bleeding and previous chemotherapy treatment underwent a radical cystectomy, l nephro-ureterectomy with formation of ileal conduit, and sigmoid colectomy with end colostomy on (b)(6) 2017.As reported, nothing was noted immediately.Five days post-operatively patient given stat aspirin for probable cerebrovascular accident (cva).Subsequently cva was ruled out.Two weeks post-op the patient complained of sharp stabbing pain in the perineum.On computerized tomography (ct) scan on 01sep2017, there was a large collection of fluid on the ipsilateral side and the stent had gone through the cortex of the kidney.No hydronephrosis.The stent was left in-situ but repositioned by pulling it back under x-ray guidance while the patient remained awake on (b)(6)2017.The stent was removed by the stoma nurse approximately 3 weeks later.No complications from the stent observed.As reported, no long term sequela expected.
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