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

Catalog Number 020015-S13

Device Problem Material Separation (1562)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 03/25/2015

Event Type  Injury  

Event Description

The device was used for retrograde pyelography with an ureteroscope inserted transurethrally.When the device was advanced over a wire guide placed in the urinary bladder, the physician confirmed that an unknown foreign matter was floating in the urinary bladder.The user removed the device once to check the device tip, then found that the catheter was fractured and partially missing.From the ureteroscopic images, it seemed that approximately 2mm of the catheter segment had separated.The user stopped using the device and another device was used instead with no problem.Although the ureteroscope was not investigated after the event, it is highly probable that the segment had already been expelled naturally with the urine if it was only 2mm size of a foreign matter.There have been no adverse effects to the patient reported.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Dimensional verification and a review of the complaint history, drawing, quality control (qc) and a visual inspection of the returned opened and used device was conducted during the investigation process.The device was measured and was found to be missing the distal most 2-6mm of the tip.Damage was also noted at the tip.A clean, spiral type cut on the distal most face of the catheter was also found.Based on the visual examination of the device, it appears that it has been damaged by an instrument of undetermined origin, causing the distal 2-6mm of the tip to separate.The tip of the catheter is 100% verified by quality control personnel, ensuring the correct length, that it is free of occlusions and that the tip is round and smooth.The appropriate internal personnel have been notified and we will continue to monitor this device.Per the quality engineering risk assessment (qera), no further risk reduction is required.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK, INC.; spencer IN 47460
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4730799
• MDR Text Key: 5740501
• Report Number: 1820334-2015-00241
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002161931
• UDI-Public: (01)00827002161931(17)150801(10)U2236978
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: 020015-S13
• Device Lot Number: U2236978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2015
• Device Age: 19 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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