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

Catalog Number 020015

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while a clinician was performing an unspecified procedure using a cook open-end ureteral catheter, the product broke in the bladder.According to the clinician all parts were retrieved.The product is no longer available for evaluation, but the packaging was kept.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the procedure, patient information including outcome, and concomitant devices.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not received for an evaluation.A document based investigation was conducted including a review of complaint history, the device history record, and quality control data.A review of the device history record found there are no non-conformances related to this incident.A review of complaint history records revealed no other complaints associated with the complaint device lot number 9130299.The device history records were reviewed for the lot and no anomalies were identified.No other complaints have been reported for the same device lot as the complaint device.A review of the production processes and quality control inspection procedures did not identify any gaps.The complaint device was not returned, so a returned device evaluation could not be carried out.The cause of the reported issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.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.

Event Description

There has been no new event information received since the last report was submitted.

Event Description

Additional information provided by customer on 18jan2019: per the physician's operative notes: procedure: right extracorporal shockwave lithotripsy, cystoscopy with right ureteral stent placement and cystoscopy with left ureteral stent removal, and removal of right nephrostomy tube.I then returned back to the bladder and placed a yellow open-ended catheter through the cystoscope into the bladder.As i was clearing the air from that catheter by injecting some contrast, the injection appeared to leak and the catheter appeared to have fragmented in half.I removed the catheter from the cystoscope, distal portion, and the proximal portion was still within the cystoscope as well, and i was able to remove this as well.We changed out to a new yellow open-ended catheter, and i placed this into the right distal ureter.Per the initial reporter, unknown if there were any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Additional information provided.

• Brand Name: OPEN-END 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: 8223544
• MDR Text Key: 132356751
• Report Number: 1820334-2019-00036
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)210830(10)9130299
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: 020015
• Device Lot Number: 9130299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU
• Patient Age: 84 YR
• Patient Weight: 74