MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 021305

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user facility reported during a surgical cystoscopy procedure being performed on an (b)(6) year-old male patient, the open-end flexi-tip ureteral catheter broke inside the patient¿s bladder.The fragment was retrieved with some sort of instrument during the initial surgery.There has been no report of any adverse effects to the patient due to this occurrence.Additional event, patient and device information has been requested from the user facility.No new information has been received at the time of this report.

Event Description

No new event information has been received since the last report submission on (b)(6) 2018.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Conclusion codes: cause cannot be traced to device ((b)(4)).Adverse event related to procedure ((b)(4)).Investigation ¿ evaluation a visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, drawings, and specifications.One used 5fr flexible tip pollack catheter rpn 021305 was received; the device was returned in two segments.The distal segment of the catheter separated 23cm from the distal tip.The proximal segment measured 47.3cm from the point of separation to the proximal end.The 050010 adapter remained on the proximal end.The total length of both returned catheter segments measured 73.3cm.There is no evidence of any missing pieces.Under magnification the edges of the angle cut were jagged.In addition, scrape marks were observed below the cut.The point of separation has mating fractures.The catheter has been cut then pulled to separation.No manufacturing anomalies were observed with the catheter.A review of the device history lot record noted there were no non-conformances noted for lot 8753553.A search of complaint records revealed this is the only complaint associated with lot 8753553.A review of manufacturing and inspection processes identified that the devices were inspected and samples from the lot were pull tested.No manufacturing anomalies were found in the document review or observed in the returned catheter.The separation point characteristics of the returned device combined with the scrape could indicate that the catheter came into contact with another device that partially cut it and then it separated when a force was applied to it.The cause of the complaint is possibly related to the catheter coming into contact with another device during the procedure.The cause cannot be traced to the device; adverse event related to procedure.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.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7713841
• MDR Text Key: 114837942
• Report Number: 1820334-2018-02186
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)210405(10)8753553
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2021
• Device Catalogue Number: 021305
• Device Lot Number: 8753553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR