MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem Discomfort (2330)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook dilator 4-6fr, trocar needle 18g, boston scientific j wire curve 0.035" 80cm.(b)(6).Occupation: director of department.Pma/510(k) #: exempt.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 a female patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an abdominal pigtail catheter drain insertion.During the procedure, the operator released the locking mechanism, "but the pigtail retaining wire did not." the catheter was cut to release the "pigtail retaining wire" to facilitate removal.The patient experienced "significant pain and distress." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

A review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned so a physical examination could not be performed.Since relevant dimensions could not be measured against specification, the device cannot be confirmed to be measured against specification.However, a document based investigation evaluation was performed.Sufficient controls are in place to detect this failure mode prior to release and the risks of this device are acceptable when weighed against the benefits.The lot number of the complaint device was not provided.However, review of the sales to the user facility over the past three years narrowed down the potential lot number to three lots.All three of these potential lots showed one related nonconformance.All nonconforming devices were scrapped, and all remaining devices in the lot underwent quality control activities such as verifying suture length and lack of stringing hole damage.A database search revealed no complaints from the three potential lots at the time of investigation.Since these 100% inspection procedures are in place and no other complaints have originated from this lot, there is no evidence that nonconforming product exists in house or in the field.Without a physical evaluation, it cannot be definitively confirmed why the loop would not disengage.It is possible that the biological matter that was being drained contributed to the suture being stuck in some way, but this cannot be confirmed without additional information.Based on the information provided, no returned product and the results of the investigation, it was concluded that a component failure unrelated to manufacturing causes contributed to the event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9311540
• MDR Text Key: 176808218
• Report Number: 1820334-2019-02848
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT6.3-35-15-P-5S-CLDM-HC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR