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 Material Separation (1562)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products:.035 terumo wire guide, cook neff percutaneous access set, bard statlock.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 that an unknown patient required the placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter as a nephrostomy tube for external drainage (unknown which kidney).After placement, the operator reported "the final plastic piece is broken or go away." the operator reports placing three devices from the same lot number during this procedure with the same failure occurring.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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.

Event Description

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

Manufacturer Narrative

Additional methods code: communication/interviews (4111).D10 ¿ product received on: 26dec2019.Investigation ¿ evaluation: it was reported three ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheters experienced hub separation from the catheter during a nephrostomy drainage procedure.Cook became aware of this event upon being notified by a doctor from (b)(6) usl n.5 -(b)(6).All three devices were replaced, and the patient reportedly experienced no additional adverse effects as a result of this incident.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, inspection of unused product, and dimensional verification, were conducted during the investigation.The complainant returned one used and nine unopened 7.0fr catheters.The used device was returned damaged and with biological matter present on the surface of the device.The catheter tubing was separated from the hub and cut into two pieces at approximately 8.5cm from the flare.Neither a tug nor twist test were able to be performed due to the damage.The distance between the hub and the cap of the used device was determined to be within specification.Seven of the nine unopened devices in this complaint all passed the tug test, the twist test, and were determined to be within specification.Three of the unopened devices failed the leak test.Of the three that leaked, two devices passed the tug test but failed the twist and the distance between the hub and the cap was determined to be out of specification.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The instructions for use (ifu) supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots revealed no related nonconformances.A database search revealed three other complaints from the complaint lot at the time of investigation.These three complaints are related complaints and are from the same user facility as this complaint.One complaint originated from the field and the other two were opened for trending purposes.There is no evidence to suggest all items in the lot or similar devices in house or in the field are nonconforming/defective.A capa was previously opened to address this issue and concluded that the main root cause was manufacturing-related.Though some of the returned devices from this lot were measured within specification for the distance between the hub and cap, it is still possible that manufacturing deficiency contributed to the device failure.Based on the information provided, examination of the returned products, and as the reported lot was manufactured prior to corrective action implementation, it was concluded that a manufacturing and quality control deficiency contributed to this incident.Corrective actions including implementation of a gap gauge and retraining were performed.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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.

• 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: 9438672
• MDR Text Key: 199726822
• Report Number: 1820334-2019-03048
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002110205
• UDI-Public: (01)00827002110205(17)220701(10)9849367
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2020

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 Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 9849367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 03/19/2020; 03/25/2020
• Supplement Dates FDA Received: 03/19/2020; 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1