MAUDE Adverse Event Report: ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER

Catalog Number H787140009045

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

The same patient has had multiple internal/external biliary drainage catheters disintegrate.They were placed on (b)(6) 2018, (b)(6) 2018, (b)(6) 2018, (b)(6) 2019, and (b)(6) 2019.All were angiodynamics 14fr 40cm biliary drain total abscession catheters.I asked if they were using anything corrosive to clean.The surgeon spoke w/ the pt.& her family and they state that they are flushing out the tube only w/ saline.While the pt.Went more than 4 weeks in between changes this time around, the surgeon said that at times he has seen deterioration in the tubing in as little as 3 weeks in between changes, in the past.Md attempted to remove as many drain pieces as he could.Pigtail was left in the patient.It was reported the defective disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation were two partial drainage catheters.The drainage catheter was returned not in its entirety.Examination by the manufacturing engineer for this product determined there was no evidence of material stretching or embrittlement at the site of the catheter fracture.This failure mode is consistent with excessive force being applied to the suture, most likely the result of difficulty in extraction of the device.The customer's reported complaint description of "the drainage catheter broke off" is confirmed.The catheter tubing was observed to be within dimension specification and there was no evidence of material stretching, nor were there any obvious visual indications of damage during manufacture that could have led to compromised integrity.The cause of the difficulty cannot be conclusively ascertained, but the failure mode is consistent with material breakdown due to exposure to an incompatible substance, possibly alcohol.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The instructions for use (ic 188) which is supplied to the end user with this catalog number states, "warnings: do not use this catheter with alcohol.Placing a 10 french or larger catheter as the primary drain before formation of a tract may be difficult in some patients.In these patients, the initial biliary drainage should be started with a smaller (8 french) catheter until a suitable tract allows placement of a larger catheter.Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.This catheter should be evaluated by the physician on or before 90 days post placement." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint#: (b)(4).

• Brand Name: TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
• Type of Device: TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8784798
• MDR Text Key: 150836059
• Report Number: 1319211-2019-00066
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787140009045
• UDI-Public: H787140009045
• Combination Product (y/n): N
• PMA/PMN Number: K002101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: H787140009045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR