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

Catalog Number 021305

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: preamendment.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that when the urologist was using the open-end flexi-tip ureteral catheter, it sheared and broke during a cystoscopy procedure.The sheared portion of the device was able to be removed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation/evaluation: the open-end flexi-tip ureteral catheter was not returned for evaluation.A physical examination could not be performed on the actual device.Photos of the device were provided.A review of complaint history, the device history record, instructions for use and quality control data was performed.The provided photos show the device sheared into two pieces.The photo shows both pieces of the device.The device history record for the product/lot was reviewed and no non-conformances were identified during the manufacturing process.A review of complaint history revealed there are no other complaints associated with the complaint device lot number.A review was carried out of manufacturing processes and no anomalies were found.Inspection processes include testing a sample of products for tensile strength and a review of the lot records found all samples exceeded the tensile test requirement.Without the device and based on the provided information a definitive cause for the reported issue could not be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

An 11fr cystoscope was used.

• 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
• MDR Report Key: 7435989
• MDR Text Key: 106192000
• Report Number: 1820334-2018-00968
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)201115(10)8375662
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR