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

Catalog Number 021305

Device Problem Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported during a pyelogram procedure being performed on a pediatric female patient, when the open-end flexi-tip ureteral catheter was being inserted into the ureter, part of the tip separated from the device.They did not know that it was broken until the catheter was removed in the middle of the case.The fragment was retrieved from the patient's ureter.It was flushed out from the ureter into the bladder and grasped with a grasper.The procedure was completed as normal.No portion of the device remained in the patient¿s body.No additional procedures were required due to this occurrence.As reported, there were no adverse effects on the patient.

Manufacturer Narrative

Investigation: a review of the complaint history, device history record, drawing, specifications, dimensional verification, and a visual inspection of the returned device were conducted during the investigation.Open-end flexi-tip ureteral catheter (lot7275550) was received.The used catheter was returned in two segments.Upon visual examination the catheter had been sliced at an angle between the first and second ink band.The bonded tip remained securely attached to each segment.The segments mated together.A review of the device history record revealed two non-conformances associated with the device lot number.These non-conformances are not related to the reported failure mode.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.It should be noted there were no other reported complaints for this lot number.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the available information and investigation results of the returned device, a definitive root cause of this event is product use or handling related as the reported damage was caused by unknown device.We will continue to monitor for similar complaints.As per quality engineering risk assessment no further action is required.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6876925
• MDR Text Key: 86689650
• Report Number: 1820334-2017-03238
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)190915(10)7275550
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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