MAUDE Adverse Event Report: COOK INC ULTRATHANE 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 Type  malfunction  

Manufacturer Narrative

Date of event: event occurred sometime in the "last 4-6 months".Occupation: regional lead.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 an ultrathane mac-loc locking loop multipurpose drainage catheter was selected for drainage.After "palcement", the hub dislodged from the catheter.It was reported the catheter was not pulled on, "it just came apart." this failure was experienced 2-3 times over the last 4-6 months.It is currently unknown if all of these failures were related to the same patient.No other adverse effects were reported for this incident.

Manufacturer Narrative

H6 - additional methods code: communication/interviews (4111).Investigation ¿ evaluation.It was reported an ultrathane mac-loc locking loop multipurpose drainage catheter was selected for drainage.After placement, the hub dislodged from the catheter.It was reported the catheter was not pulled on, "it just came apart." this failure was experienced 2-3 times over the last 4-6 months.No other adverse effects were reported for 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 was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 affected lot number was not reported to cook during intake of this complaint.A search of all lots sold to the reporting customer on the reported rpn in the past three years prior to the date cook was made aware of this complaint found 5 potential lots.The device history records (dhrs) for the potential lots were reviewed, and found one reported nonconformance relevant to the reported failure mode in one of the potential final lots.All nonconforming product was scrapped, the device goes through a 100% inspection for the reported nonconformance, and there are no additional complaints from the field on any of the five potential lots.Based on this information, there is no evidence suggesting that nonconforming product from these potential lots exists in house or in the field.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 capa was previously opened to address this issue.The capa investigation determined root causes and implemented corrective actions.Based on the information provided, no returned product, and the results of the investigation, 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.

Event Description

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

• Brand Name: ULTRATHANE 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: 9437110
• MDR Text Key: 184758447
• Report Number: 1820334-2019-03039
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1