MAUDE Adverse Event Report: COOK INC ROUND TIP URETERAL CATHETER; CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 024103

Device Problem Break (1069)

Patient Problem Foreign body, removal of (2365)

Event Date 03/10/2015

Event Type  Injury  

Event Description

During a cystoscopy procedure, when the device was removed from the patient; the physician noticed that the body of the catheter was broken.Additional information provided 07april2015: the device broke inside the bladder.The broken device was removed with cystoscope.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Manufacturer Narrative

(b)(4).Product was returned in an opened and used condition.A review of the complaint history, quality control (qc) and a visual inspection on the returned product was conducted.The visual inspection noted that the catheter had separated and two pieces of the catheter shaft were returned (~1.2 cm and ~1 cm).The separated pieces appeared to have jagged, uneven edges as if the catheter had seen forces beyond its design.Quality check specification states to check to make sure the tip is round and smooth.The patient event information states: "the device broke when put into the bladder, so there's no calcified or tortuous.And because it was broken in the bladder, there's nothing remain in patient's body, they removed it with cystoscope." the appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), no further risk reduction is required.

Event Description

During a cystoscopy procedure, the physician removed the device and found the catheter was broken.There was nothing left inside patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.Additional information provided 04/07/2015.The device broke upon insertion into the bladder.There was no calcification nor was the device path tortuous.The broken portion of the catheter was removed with a cystoscope.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ROUND TIP URETERAL CATHETER
• Type of Device: CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4685516
• MDR Text Key: 5675604
• Report Number: 1820334-2015-00239
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 0082700214024
• UDI-Public: (01)0082700214024(17)170815(10)5198828
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2017
• Device Catalogue Number: 024103
• Device Lot Number: 5198828
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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): Required Intervention