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 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 used in an unknown patient for a percutaneous transhepatic biliary drainage procedure.As reported by the user, the metal stiffening cannula was unable to be removed from the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No additional patient or event information has been received since the last report was submitted on (b)(6) 2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.D10 ¿ product received on: (b)(6) 2019.Investigation ¿ evaluation.A visual inspection, dimensional verification, and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, manufacturing instructions, the instructions for use, quality control data and specifications.The complaint device was returned to cook for investigation.Investigation of the returned device showed that the cannula was protruding through the distal tip of the catheter, and the cannula was able to be removed from the catheter by relaxing the distal catheter tip over the cannula.Dried biomatter was noted on the cannula, but no other surface damage was noted to either device.All dimensions deemed relevant to the failure mode were analyzed and found that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Adequate risk controls, including drawings and quality control instructions are in place to inhibit this failure mode.This analysis indicates that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record for the complaint lot and related subassembly lots found one non-conformance related to the reported failure mode.Due to the relevance of the nonconformance, further investigation was necessary.To investigate, a search of all final catheter lots this subassembly is included in was conducted, producing a list of four additional lots.A review of complaint history records shows no other complaints associated with the complaint device lot or the four additional lots.The reported device goes through a 100% inspection for the reported nonconformance, and all nonconforming products were scrapped, suggesting that there is no evidence of nonconforming product from this lot or additional lots in house.Due to no additional complaints from the five total lots being reported from the field, there is no evidence suggesting that nonconforming product from this lot or the additional lots exists 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.Appropriate measures have been taken to address this failure mode.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 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: 8875112
• MDR Text Key: 154568088
• Report Number: 1820334-2019-01967
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220322(10)9612456
• 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: 10/30/2019

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: 03/22/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9612456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1