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 Code Available (3191)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: exempt.(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 an unknown patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for nephrostomy drainage.The catheter was placed on (b)(6) 2020.On (b)(6) 2020, the patient returned with the catheter disconnected at the mac-loc.The catheter was exchanged for another similar device without any problems.No adverse effects were reported.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation.Hospital (b)(6) in spain informed cook that the hub on an ultrathane mac-loc locking loop multipurpose drainage catheter from an unknown lot separated after placement.The catheter was placed on (b)(6) 2020.On (b)(6) 2020, the patient noticed the catheter hub was separated.The device was removed and replaced without adverse effects to the patient.A review of the complaint history, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection of a photo of the complaint device provided by the user, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did provide a photo of the catheter.The hub is separated and the flare is intact.Additionally, a document based investigation evaluation was performed.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the 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.Inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.The lot number for the complaint device was not provided.A search of lots sold to the customer in the three years prior to the event was unable to identify the lot.Therefore, the device history record could not be reviewed.There is no evidence of nonconforming material in house or in the field.A capa was previously opened for this product issue.The capa investigation implemented corrective actions related to manufacturing and quality control.Because the lot number is unknown, it is unknown whether the complaint device underwent these corrections.Based on the information provided, no returned product, and the results of the investigation, it is possible that a manufacturing or quality control deficiency contributed to this incident as determined from the capa investigation.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 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: 11078392
• MDR Text Key: 223810624
• Report Number: 1820334-2020-02359
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/21/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention