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 Difficult to Remove (1528)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an ultrathane mac-loc locking loop biliary drainage catheter was selected for use in a percutaneous biliary drainage procedure.Prior to patient contact, it was found the cannula was unable to be removed from the catheter.As reported, there were no adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control, and specifications.One device was returned for investigation.From the investigation, the cannula was confirmed stuck within the catheter, but the distal end of the cannula was protruding out of the catheter.While trying to remove the metal cannula, resistance was noted, and the cannula was unable to be removed without the catheter bunching.After relaxing the catheter¿s tip over the cannula, the cannula was able to be removed.Slight biomatter was noted on the cannula, possibly causing the removal issue.All dimensions deemed relevant to the reported failure mode were analyzed and confirmed that the device was manufactured within specification.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record found one non-conformance related to the reported failure mode.The related nonconformance was noted on the tubing subassembly lot.This tubing lot was used to manufacture two additional lot, but no additional complaints from the field were noted on these additional lots or the original reported lot.All nonconforming product were scrapped, and the device goes through a 100% inspection for the nonconformance.From this information, there is no evidence suggesting that nonconforming product from this lot or the additional lots exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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 patient or event information has been received since the last report was submitted on 29aug2019.

• 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: 8944147
• MDR Text Key: 156740563
• Report Number: 1820334-2019-02156
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)210719(10)9031739
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9031739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1