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 Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: pre-amendment.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 inspected prior to use.An unidentified particle was observed inside the sealed, primary packaging.No other adverse effects were reported for this incident.

Manufacturer Narrative

H6- additional methods code: analysis of data provided by user/third party (4112).Investigation/evaluation: a review of the complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation.The complaint was not returned for investigation.However, the distributor did supply photos of the complaint product.From review of the complaint photos, a fiber was noted at the bottom of the device packaging.No other evaluation was able to be completed.Due to this information, the device will be confirmed as manufactured out of specification.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is shipped with labeling which notes: "supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the device history record (dhr) for the complaint lot revealed one reported nonconformance relevant to the reported failure, however all nonconforming product was scrapped, and the device is 100% inspected for the nonconformance.A database search revealed no other complaints have been reported for the device lot.There is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Based on the information provided, no returned product and the results of the investigation, it was concluded that a manufacturing and quality deficiency contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: 9283910
• MDR Text Key: 165269811
• Report Number: 1820334-2019-02796
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220531(10)9777904
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9777904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1