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 Fluid/Blood Leak (1250)

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

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).510k status: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The international customer reported that, after the ultrathane mac-loc locking loop biliary drainage catheter was inserted into the patient, the operator of the device discovered that contrast medium was leaking from a joint in the catheter.The operator withdrew the device, and replaced it with a new catheter.The procedure was completed successfully, with no additional procedures necessitated by the product issue, and no patient adverse events occurring as a result.The complaint device has been returned for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, dimensional verification, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed evidence of bio matter on the catheter, indicating it was likely used.No damage was noted on the catheter.The catheter was tugged and it felt securely attached.Similarly, the cap was twisted and it felt securely attached.The catheter was leak tested and a leak was detected at the distal end of the cap between the cap and the catheter.During disassembly, the cap could not be cleanly removed from the fitting.Thus, the flare diameter, cap inner diameter, and fitting distal inner diameter could not be measured.The number of threads between the mac-loc and cap and the catheter tubing outer diameter were found to be within cook's manufacturing specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause has not been determined.This failure mode has been escalated per internal processes.The appropriate personnel have been notified, and this failure mode will continue to be trended.Per the quality engineering risk assessment, no further action is required.

• 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 ; 8123392235
• MDR Report Key: 7342429
• MDR Text Key: 102597118
• Report Number: 1820334-2018-00717
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)201030(10)8331951
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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: 73 DA
• Patient Weight: 62