|
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: organ(s), perforation of; not labeled, thromboembolism; not labeled 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 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 # 1820334-2017-03245.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.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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: organ(s), perforation of; not labeled, thromboembolism; not labeled 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 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 # 1820334-2017-03245.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.
|
|
It was reported on (b)(6) 2017, a 65-year-old male patient with bladder cancer and incidental adenocarcinoma of the prostate underwent a radical cystoprostatectomy, lymph node dissection and formation of an ileal conduit using the bander ureteral open end stent set.As reported, nothing was noted immediately.Four days post operatively, patient¿s temperature was raised and his abdomen distended.His white cell count (wcc) was also elevated.Computerized tomography (ct) scan showed dilated jejunal small bowel loops, post-operative ileus likely cause.No significant intra-abdominal collection.The stent had gone through the cortex of the kidney.The stent was left in-situ but repositioned in theatre by pulling it back under x-ray guidance while the patient was awake.Patient suffered an episode of venous thromboembolism within 90 days of discharge.Presented separately and investigated by vte team.No concerns with care.As reported, there is no long term sequalae or consequence due to occurrence with stent.
|
