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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

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 customer reported that, during the removal of the catheter, it broke and completely detached.The device was extracted from the patient's bladder successfully, with all pieces of the device accounted for.

Manufacturer Narrative

Investigation ¿ evaluation: the open-end flexi-tip ureteral catheter was not returned for evaluation.Therefore, a physical examination could not be performed on the actual device.Photos of the device were provided.There is no evidence to suggest the product was not manufactured to specifications.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.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 lot number 7600677.Based on the provided information a definitive root 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.

• 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: 6749751
• MDR Text Key: 81230181
• Report Number: 1820334-2017-01864
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)200118(10)7600677
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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: 021305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• Date Device Manufactured: 01/18/2017
• 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