MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: manager.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 an unknown patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for a liver drainage procedure.Prior to patient contact, the operator "could not get the guidewire through the device".The complaint device was returned, and a manufacturer device analysis concluded a "green plastic like piece was found to be blocking the tip".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 03feb2020.Investigation ¿ evaluation: it was reported that a ultrathane mac-loc locking loop biliary drainage catheter could not advance the wire guide through the device, a green plastic like piece was found blocking the distal tip during a liver drainage procedure.The device reportedly did not make patient contact.Another device of the same type was used to successfully complete the procedure.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection and functional test, were conducted during the investigation.The complainant returned a ultrathane mac-loc locking loop biliary drainage catheter to cook for investigation.Physical/visual examination of the returned device showed biomatter present on the drainage catheter.The clear flex stiffener was fully inserted in the catheter.A 0.038¿ wire guide was inserted into the catheter proximal hub, with the stiffener inserted, and it would not exit the distal tip.The stiffener was removed, no damage was found.The wire guide was reinserted into the catheter hub and it did not exit the catheter distal tip.The wire guide was inserted through the distil tip of the catheter and a green plastic like material was found blocking the distal tip.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) was also reviewed.The dhr for the complaint lot and related subassembly lot recorded no relevant non-conformances.A nonconformance search for similar nonconformances was completed for the timeframe the complaint was manufactured and for the manufacturing work center where the device was built and revealed no similar non-conformances/affected product.A complaint data base search revealed no additional complaints for the complaint lot from the field and no similar complaints for distal blockage.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) supplied with the multipurpose drainage catheter provides the following information to the user related to the reported failure mode: how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned product, and the results of the investigation, it was concluded that the main cause of the failure is manufacturing related.The failure due to manufacturing was confirmed by the production manager.She stated that the dislodged green plastic piece "looks to be the support tubing that is used during the forming process" that should have been removed.Retraining was completed for the quality control personnel responsible for the quality control inspection(s) related to the failure.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 MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9770605
• MDR Text Key: 181954482
• Report Number: 1820334-2020-00502
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094994
• UDI-Public: (01)00827002094994(17)221104(10)10126167
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Device Lot Number: 10126167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1