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

Catalog Number 021304

Device Problems Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 during a cystoscopy retrograde pyelogram procedure while using the open-end flexi-tip ureteral catheter, parts of the catheter sheared off as ¿chips¿.Some of the chips ended up in the patient¿s bladder and were removed successfully with grasping forceps.The karl storz pediatric cystoscope was looked at by the storz representative and they advised that there is a slight bend in the scope and believe this caused the shearing of the catheter.As reported, the product is not available for return and the lot number is not available.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

The device was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation was performed.A review of the instructions for use, quality control data, and specifications was conducted.The device history record could not be reviewed as the lot number of the complaint device was not provided.A review of complaint history for the complaint device lot number could also not be performed without the lot number.Based on the information provided, there is no evidence that the complaint issue is the result of a manufacturing non-conformance or other failure that might affect additional devices in the field or in-house.Inspection of the storz scope used with the catheter was performed by the storz representative.The storz representative indicated the scope may be the cause of the reported issue.As indicated by clinical assessment of the complaint information, the reported ¿chips¿ are likely the result of cystoscope function.Per the quality engineering risk assessment, no further action is warranted.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.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.

• 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: 7317527
• MDR Text Key: 101631360
• Report Number: 1820334-2018-00593
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 021304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention