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 Foreign body, removal of (2365)

Event Type  Injury  

Event Description

They removed the catheter from the package.They then placed the catheter over the wire and fed it through the cystoscope.The catheter was not advancing well and it seemed too short.They removed the catheter from the cystoscope and discovered that it had broken in half.Only half of the catheter came out of the cystoscope.They took fluro to try to find the other half of the catheter and could not find it in the pt's body.They removed the cystoscope from the pt and the other half of the catheter fell out of cystoscope into the table drain bag.No scissors or lasers were used in this procedure.The procedure was completed successfully with a new catheter of the same type.A section of the device did not remain inside the pt's body.The pt did not require any additional procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4036813
• MDR Text Key: 4879562
• Report Number: 1820334-2014-00387
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2014,07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 021305
• Device Lot Number: 4992520
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other