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

Model Number N/A

Device Problems Break (1069); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

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

It was reported that the physician was performing ureteroscopy procedure on a patient by using spiral tip ureteral access catheter.During the procedure, the tip of the device broke off inside the patient.The physician drained the patient's bladder to remove the broken piece of the tip.No unintended section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information has been provided at this time.

Manufacturer Narrative

Corrected information: device not returned to manufacturer investigation ¿ evaluation: a review of the complaint history, device history record, documentation, and specifications was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device could not be performed.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 and device integrity prior to shipping.A review of device history record revealed two non conformances, however these non-conformances were not associated with the reported failure.A complaint history query revealed this complaint to be one of two (2) complaints associated with complaint lot number.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6559967
• MDR Text Key: 74937097
• Report Number: 1820334-2017-00894
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002148734
• UDI-Public: (01)00827002148734(17)190909(10)7259034
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 024505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention