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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The international customer reported that, when the radiologist went to lock the ultrathane mac-loc locking loop biliary drainage catheter into position after the catheter was placed over the wire, the locking suture snapped.The device was exchanged with another catheter.The customer confirmed that no patient adverse events resulted from the product problem.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Event or Problem Description
The international customer reported that, when the radiologist attempted to lock the ultrathane mac-loc locking loop biliary drainage catheter into place following placement over the wire, the locking suture snapped at the hub of the device.The device had to be exchanged for another catheter.The customer confirmed that no patient adverse events occurred as a result of the issue.The procedure was a biliary drainage catheter exchange.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.As this case did not involve the suture remaining in the body and did not require a different procedure at another date, it should not have been submitted as reportable and should not reflect a change to cook's handling of similar complaints.As this case did not involve the suture remaining in the body and did not require a different procedure at another date, it should not have been submitted as reportable and should not reflect a change to cook's handling of similar complaints.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device was completed during the investigation.The visual inspection of the returned device confirmed that the black suture string was broken.The string was missing from the locking mechanism.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 could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7133076
• Report Number: 1820334-2017-04462
• Device Sequence Number: 16423808
• Product Code: GCA
• UDI-Device Identifier: 00827002094994
• UDI-Public: (01)00827002094994(17)200621(10)8008103
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ WIRE
• Patient Age: 52 YR