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

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a right percutaneous nephrostolithotomy with antegrade stent placement procedure, the cook ureteral catheter was inserted and split in pieces.All pieces were retrieved, 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.The surgeon reportedly completed the procedure without further difficulty.

Manufacturer Narrative

(b)(4).Investigation - evaluation : a review of the complaint history, drawings, device history record, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the catheter split into pieces.A review of the returned device confirms a lengthwise split near the distal end of the device.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported that during a right percutaneous nephrostolithotomy with antegrade stent placement procedure, the cook ureteral catheter was inserted and split in pieces.All pieces were retrieved, 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.The surgeon reportedly completed the procedure without further difficulty.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5793516
• MDR Text Key: 49494905
• Report Number: 1820334-2016-00600
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)190308(10)6795934
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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: 62 YR