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 Obstruction of Flow (2423)

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

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The international customer reported that, when the operator advanced the ultrathane mac-loc locking loop biliary drainage catheter over the wire guide to the lesion position, the bile would not flow out even after the wire guide and inner core were removed.The operator reported that the reason for the lack of flow was some type of obstruction.No adverse events were reported as a result of the product issue, and no additional procedures were necessitated.The product is reportedly available for return; however, as of the date of this report, no product has yet been received for evaluation.

Manufacturer Narrative

Additional information: device evaluated by mfr.Corrected information: foreign, user facility, distributor, company representative.Investigation - evaluation: a review of dimensional verification, functional testing, complaint history, device history record, documentation, drawings, instructions for use (ifu), manufacturing instructions,quality control data, and visual inspection of the returned device was conducted during the investigation.One catheter was returned with the metal stiffener inserted within the lumen of the catheter.The stiffener was removed, and water was easily flushed through the lumen of the catheter.The failure was unable to be duplicated.It is possible that the drain blocked, but the blockage removed when the stiffener was inserted prior to return.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Based on the provided information, inspection of returned product, and the results of our investigation, a definitive root cause cannot determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6954057
• MDR Text Key: 89743226
• Report Number: 1820334-2017-03480
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)200320(10)7764793
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR