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

Catalog Number 021305

Device Problem Peeled/Delaminated (1454)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # - pre-amendment.(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 via sus event report number mw5078977: patient underwent cystoscopy.During the procedure, surgeon used an open-ended catheter in patient's left ureter.The surgeon threaded the catheter through the scope.After using the catheter, he attempted to remove it, but had difficulty pulling it out through the scope.After pulling out the catheter, the patient's bladder was inspected, two shavings were visualized from the catheter in the bladder.Both shavings were removed.Procedure completed.

Event Description

Follow up for additional information cannot be performed as the identify of the complainant was not provided.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photograph or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, manufacturing instructions, quality control data, and trends.The device history record was reviewed noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 8841289.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.Based on the provided information, the cause of the complaint was not able to be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.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
• MDR Report Key: 7828246
• MDR Text Key: 118893980
• Report Number: 1820334-2018-02612
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)210425(10)8841289
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Catalogue Number: 021305
• Device Lot Number: 8841289
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1