MAUDE Adverse Event Report: COOK, INC. OPEN-END FLEX-TIP URETERAL CATHETER; NEEDLE, BIOPSY, CARDIOVASCULAR

Catalog Number 021305

Device Problem Melted (1385)

Patient Problem Surgical procedure, additional (2564)

Event Date 04/10/2015

Event Type  Injury  

Event Description

The initial reporter states that the cook catheter did not fail.However, during the procedure, the physician's technique (while using another manufacturer's vessel sealer), melted 5 cm of the catheter, stent placement was needed.Per attached medsun report ((b)(4)): lap exploratory colon resection.The catheter was removed at conclusion of case and was observed to be shorter than preoperatively.An x-ray in the or (operating room) confirmed a segment of the catheter lying with in the mid left ureter.The urologist was called back into the operating room.A cystourethroscopy showed no bladder damage.A small clot, coming from the left ureteral orifice was seen.The urologist encountered at the l5 level of the left ureter, what appeared to be a thermal injury with oozing present at the 11 o'clock to 2 o'clock position extending for 2-3 centimeters.The ureteroscope demonstrated no evidence of a tear.A 6 fr contour stent was passed and in excellent condition within the collection system.The surgeon stated in a brief interview that the other manufacturer's device caused a thermal burn and attributed it to user error and not device failure.The patient was discharged to a rehab facility on op day #7.The catheter and stent were removed via forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Expiration date unknown as lot is unknown.(b)(4).The event is currently under investigation.

• Brand Name: OPEN-END FLEX-TIP URETERAL CATHETER
• Type of Device: NEEDLE, BIOPSY, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4781763
• MDR Text Key: 5853806
• Report Number: 1820334-2015-00282
• Device Sequence Number: 1
• Product Code: DWO
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2015,04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Weight: 47