MAUDE Adverse Event Report: COOK INC SPIRAL TIP URETERAL ACCESS CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 024505

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2017

Event Type  malfunction  

Manufacturer Narrative

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 the tip of the spiral tip ureteral access catheter broke off in the patient.No adverse effects or consequences were reported due to this occurrence.Additional information has been requested from the customer regarding the procedure and the patient outcome.Also requested information regarding how the tip was removed.At this time no further information is forthcoming.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: the spiral tip ureteral access catheter was not returned.No additional information was provided.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of the quality control data, and specifications was conducted.The device history record was not able to be reviewed due to insufficient lot information.A review of complaint history records was not able to be performed as the lot number was not available.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 and 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 provided information a definitive root cause cannot be established.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: SPIRAL TIP URETERAL ACCESS CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7081701
• MDR Text Key: 93831092
• Report Number: 1820334-2017-04177
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 024505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other