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 Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: manager.Reported to regulatory agency: unknown.Pma/510(k) #: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a ultrathane mac-loc locking loop biliary drainage catheter was placed in a (b)(6)-year-old female during a granular colesistoma procedure.As reported: "the drain was successfully placed on (b)(6) 2019 (right tube and a left tube).Patient bilirubin was elevated so brought the patient back on (b)(6) 2019 to potentially upsize the tubes.Wire placed in left side tube first, then in right side tube.Initial fracture not noticed upon wire placement.Physician noticed cope loop on the drain did not release and observed the fracture in the catheter.The portion of the catheter slid down into duodenum." the report states the physician used snare device and was able to retrieve the segment successfully.The report further states, ¿catheter broke a second time, and physician had to push the catheter into the duodenum to retrieve it and found it was folded on itself upon retrieval.No drains were left after the procedure.Patient went for additional surgery and had some of the carcinoma resected, but no issues were observed from the prior procedure." no other adverse effects were reported for this incident.

Manufacturer Narrative

Concomitant medical product received on: 11jun2019.Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The complaint device was returned to cook for investigation.During investigation, 2 separations were noted, one distal too the flare and the second in the sideport region.Both separations appeared to be rough, suggesting a tensile separation.All dimensions relevant to the failure mode were analyzed and confirmed that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed for the complaint lot.The dhr records one non-conformance relevant to the reported failure mode; ¿pits¿ (qty 4, scrapped) on the shaft subassembly.A search of all additional lots produced on the same day for the same shaft subassembly was conducted and found one additional completed lot.This additional lot recorded an applicable nonconformance of ¿bond, rough¿ for two devices which were scrapped.This lot was produced by a different operator, suggesting that there is no operator-specific issue.Due to all products going through a 100% inspection for catheter shaft deformities, there is no evidence suggesting that additional nonconforming product from any of these lots exist in house.A software search was completed for complaints reported on the complaint lot and all additional lots and found no additional complaints from the field.This suggests that there is no evidence that nonconforming product from the reported lots and additional lots exists in the field.Based on the information provided, inspection of returned product and the results of the investigation, cook has concluded that a component failure without manufacturing or design issue contributed to this incident.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8663656
• MDR Text Key: 146906390
• Report Number: 1820334-2019-01342
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)220108(10)9428265
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 9428265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR