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

Catalog Number 020014

Device Problem Flaked (1246)

Patient Problem Foreign body, removal of (2365)

Event Date 03/06/2014

Event Type  Injury  

Event Description

Doctor and registered nurse both said they noticed the catheter peeling off pieces when inside the pt.He went in and retrieved the pieces that broke off.Additional information received (b)(4) 2014 - the cystoscopy with retrograde studies were done at the start of the case on a 7 month old child.The 4fr ureteral open ended catheter by cook was used then.They used a wolfe 9.6fr offset pediatric lens for the case that accepts up to 5fr in the channel.A.025 glidewire was used by boston scientific.A disposable alligator forcep by cook was utilized to remove the particles found int he bladder.The case proceeded and was completed as noted by the above procedure.Pt is currently doing fine, recovering.

Manufacturer Narrative

Event evaluation: still under investigation.

Manufacturer Narrative

(b)(4).During the investigation, a review of complaint history, drawing, quality control and a dimension verification and visual inspection of the returned device were conducted.One used device was received and visually inspected to find scrape marks starting approximately 45cm from the distal tip and concluding less than 1cm from the distal tip.Included with the device were shavings that were scraped off the side of the catheter.The customer stated "they noticed the catheter peeling off pieces when inside the patient.He went in and retrieved the pieces that broke off." the device had obviously been damaged by an instrument of undetermined origin.As the user pulled or pushed the device past a sharp portion of the instrument, the catheter scraped against it and created shavings.There is no evidence to suggest product was not manufactured to specifications.Quality engineering risk assessment was used to assess the risk of this complaint.Per conclusion, no further risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

Doctor and rn both said they noticed the catheter peeling off pieces when inside the patient.He went in and retrieved the pieces that broke off.Additional information received march 13, 2014, the cystoscopy with retrograde studies were done at the start of the case on a (b)(6) child.The 4fr ureteral open ended catheter by cook was used then.They used a wolfe 9 6fr offset pediatric lens for the case that accepts up to 5fr in the channel a 025 glidewire was used by boston scientific.A disposable alligator forcep by cook was utilized to remove the particles found in the bladder.The case proceeded and was completed as noted by the above procedure.Patient is currently doing fine, recovering.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3736002
• MDR Text Key: 17157237
• Report Number: 1820334-2014-00143
• Device Sequence Number: 0
• Product Code: GBL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 020014
• Device Lot Number: U2293083
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• 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): Required Intervention
• Patient Age: 7 MO