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 Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(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 the open-end ureteral catheter was being inserted over the wire through the scope, and did not feel "natural" to the physician.The physician took the scope out and found the catheter had snapped off clean.The patient¿s anatomy was not scarred, calcified, or tortuous.The physician retrieved the broken catheter with his hand.A new catheter had to be inserted to complete the procedure.Insertion of the new catheter added an additional two minutes to the procedure.No portion of the device was left in the patient.The patient did not experience any adverse effect(s) due to this event.The patients outcome post procedure was "ok".

Manufacturer Narrative

H6 - method codes: 4114, device not returned.H6 - conclusion codes: 4135, cause not established.Investigation ¿ evaluation the complaint device was not returned for an evaluation and no photograph or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, quality control data, and trends.The device history record was reviewed noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 8907102.The device is inspected visually and functionally for cracks and fractures by manufacturing and quality control and no notable gaps in production or processing controls were noted.Based on the available information, the cause of the complaint was not able to be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.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 information received since the last report was submitted.

• 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: 7868508
• MDR Text Key: 119957130
• Report Number: 1820334-2018-02617
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)210524(10)8907102
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Catalogue Number: 020015
• Device Lot Number: 8907102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYSTOSCOPE AND SENSOR WIRE; CYSTOSCOPE AND SENSOR WIRE
• Patient Age: 66 YR
• Patient Weight: 80