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

Catalog Number 021305

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: preamendment.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 that as the catheter was being removed after completion of the procedure, a shaving or fragment of the catheter remained inside the patient.It was quickly and easily retrieved with graspers.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

Additional information was received on 12jul2018: it was reported the procedure was a cystoscopy with stent placement.The surgeon said there was some tension on insertion/removal of the catheter but not much.As reported, nothing out of the normal.Also, the patient is doing well.

Manufacturer Narrative

Correction: event or problem: information inadvertently missed in the initial report.Evaluation / investigation: a visual inspection of the returned device was conducted.A review of the manufacturing instructions, quality control data, and specifications was also performed.One specimen cup with a 021305 catheter inside was received.; the adapter was not returned with the catheter.Two yellow and black shavings were attached to the lid of the cup with tape.The length of the catheter was 69.4cm.Under magnification scrape marks were observed along the catheter starting at the 24cm ink mark and continued down to the 43cm ink mark.The length of the scrape measured approximately 19cm.No manufacturing anomalies were observed on the catheter.The device history record was not able to be reviewed as the lot number of the complaint device was not known.A review of complaint history for the associated device lot could not be performed without the complaint device lot number.After review of the returned product it was concluded that the device had likely been damaged by another device during use.Based on the procedure a cystoscope was used.The cause of this complaint is likely the catheter was abraded by a cystoscope.Unintended use error caused or contributed to this event.Per the quality engineering risk assessment, no further action is warranted.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: 7689549
• MDR Text Key: 114023614
• Report Number: 1820334-2018-02138
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1