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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2017

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

It was reported that the physician performed a cystoscopy prior to extracorporeal shock wave lithotripsy (eswl) procedure of kidney stone and inserted an open-end flexi-tip ureteral catheter inside the patient.When the physician removed the ureteral catheter out of scope, a small fragment remained inside the bladder of the patient.This fragment was seen on the video monitor.The physician retrieved the fragment with help of grasper.The intended eswl procedure was completed and 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

Investigation - evaluation: the open-end flexi-tip ureteral catheter was not returned/received for an evaluation.The customer report of a small shredded segment came off in the patient¿s bladder could only be confirmed based on the customer¿s testimony.Based on the information provided a definitive root cause could not be established.Should the device be returned at a later date an evaluation will be performed and a follow-up report will be filed.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.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the identified product issue.A review of complaint history revealed this complaint to be the only complaint received that is associated with this product/lot number combination.Per the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the 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: 6600916
• MDR Text Key: 76285877
• Report Number: 1820334-2017-01047
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)200302(10)7720526
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/08/2017
• Date Device Manufactured: 03/02/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 72