MAUDE Adverse Event Report: COOK INC SOF-FLEX MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Model Number G17852

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510k # k180053.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.(b)(4).

Event Description

User facility(uf) medwatch report number (b)(4) was received 15jul2020.The uf report showed the facility reported, "a 1cm piece of a 4.7 multi-length stent was retained in patient while performing a cystoscopy/ureteroscopy/stone removal procedure".Additional information was received 27jul2020: the stent was initially placed because the patient had kidney stones.The section of the stent that was removed was encrusted.The alleged malfunction did not cause or contribute to the need for additional procedures.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

Additional information was received 22sep2020.The device was removed by the urologist from the patient (b)(6) 2020 and sent for pathology.Alligator graspers were used to grasp the stent and pull it to the meatus and was removed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Event summary: it was reported that "1 cm piece of stent was observed retained in patient.¿ as reported, a 10-year-old male, required use/placement of a sof-flex multi-length ureteral stent set for treatment of kidney stones.The patient underwent a cystoscopy/ureteroscopy/stone removal procedure.The operator reported that during the removal procedure a 1cm piece of a 4.7cm multi-length stent was retained in the patient.The stent was removed by the urologist using alligator graspers.The stent was pulled through the meatus of the patient and fully retrieved.The operator did note that the stent did have encrustation present.The operator reported that there were no adverse effects to the patient as a result of this malfunction.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, drawings, specifications, and quality control data.Visual examination confirmed the stent only was received in a used condition; the remaining set components were not returned.Both coils on the stent were stretched out of shape; the overall length measured 30.5cm.The area between the distal double in band and the proximal quadruple ink bands measured approximately 10cm.The distal coil was stretched and the end of the coil had a frayed melted appearance; a section of the distal coil was missing and was not returned.Several areas along the stent were damaged with a melted appearance and holes penetrating the material.Pinch marks and puncture holes made by an instrument such as forceps or some type of grasper were visible.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of manufacturing procedures found that current controls for manufacturing and quality control are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: formation of knots in multi-length stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.Precautions: complications of ureteral stent placement are documented in literature.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.The endo-sof¿ stents must not remain indwelling more than twelve (12) months.The sof-flex®, lse sof-flex®, c-flex®, and aq® stents must not remain indwelling more than six (6) months.If the patient¿s status permits, the stent may be replaced with a new stent.These stents are not intended as permanent indwelling devices.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.A pregnant patient must be more closely monitored for possible stent encrustation due to calcium supplements.Improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.Individual variations of interaction between stents and the urinary system are unpredictable.Possible causes for this event such as product handling, medical procedure, device failure, or manufacturing related causes could not be eliminated as possible causes.The cause of the complaint is a component failure.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• Brand Name: SOF-FLEX MULTI-LENGTH URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10343225
• MDR Text Key: 201010631
• Report Number: 1820334-2020-01382
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002178526
• UDI-Public: (01)00827002178526(17)220205(10)9500396
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: G17852
• Device Catalogue Number: 039500-8-20
• Device Lot Number: 9500396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 09/22/2020; 10/09/2020
• Supplement Dates FDA Received: 10/07/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 10 YR