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 Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: preamendment.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 an unknown patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for biliary drainage.The operator stated an "over wire- micropuncture" technique was used and no resistance with insertion or removal of any components was experienced.The drainage catheter had saline, contrast, and bile within in the system and was connected to a drainage bag.Upon final inspection, the operator noted a leak "where the tube meets the hub." the drain was immediately replaced with a similar device and no further issues were noted.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

D10- concomitant medical product received on: 10dec2019.Investigation-evaluation.It was reported to cook that the hub of the catheter within an ultrathane mac-loc locking loop biliary drainage catheter was leaking.This incident was reported by (b)(6) hosp, in canada, on 26nov2019.The device was removed, and another was placed to successfully complete the procedure.No adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned a mac-loc hub with a segment of tubing attached.The segment was covered in a yellow liquid.No other surface damage was noted to the device.A tug and twist test confirmed that the flare was securely seated within the hub.The hub was leak tested and confirmed a leak where tubing enters the cap.All dimensions deemed relevant to the reported failure mode were analyzed and found that the device was within specifications.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) was reviewed.The final lot on hub assembly lot, tubing assembly lot, and raw material lot revealed one relevant nonconformance.Although the reported nonconformance is relevant to the failure mode, all nonconforming product was scrapped, the device goes through a 100% inspection for the nonconformance.In addition, no other complaints have been reported from the field on the reported lot.Due to this, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.The instructions for use (ifu) supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A capa was previously opened to address this issue.The capa investigation determined root causes and implemented corrective actions.Based on the information provided, inspection of the returned product, and as the reported lot was manufactured prior to corrective action implementation, it was concluded that a manufacturing and/or quality control deficiency contributed to this incident.Although the device was measured within specification, it is possible that a manufacturing or quality control deficiency could have caused the failure.Corrective actions including implementation of a gap gauge and retraining were performed.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cool 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: 9439180
• MDR Text Key: 184755849
• Report Number: 1820334-2019-03050
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)210521(10)8896702
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 8896702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1