MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / EXODUS; BILIARY DRAINAGE CATHETER

Catalog Number	H965105261
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The catheter from the reported event has been returned to angiodynamics, however the device evaluation has not yet been conducted.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported 10f drainage catheter which had been in place in the biliary tree (duodenum) for 3 weeks, fractured.The physician had to remove the tip via a snare.The used catheter has been returned to angiodynamics.The patient condition was reported as, "unaffected.".
Additional Manufacturer Narrative
The recent angiodynamics complaint report was reviewed for the exodus drainage catheter product family and the failure mode "tip fractured/migrated." no adverse trend was identified.The reported device lot, as well as the returned sample were forwarded to angiodynamics' contract manufacturer for this device (freudenberg medical) on a supplier corrective action request form (scar).Freudenberg confirmed the reported failure, but was unable to determine the cause of the event.Their review of the device history records for the noted lot found no observations that would indicate the reported condition was the result of a manufacturing defect: the catheter tubing was found to be within dimensional and material specifications.The directions for use provided with the device includes the following information: "indications for use / intended use: exodus believe biliary drainage catheters are intended for percutaneous drainage of the biliary tree.Warnings: do not use catheter for gastrostomy procedures/feeding tube.Exposure to gastric juices may damage the catheter.Instructions for use: note: 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." (b)(4).

• Brand Name: ANGIODYNAMICS / EXODUS
• Common Device Name: BILIARY DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8141227
• Report Number: 1317056-2018-00224
• Device Sequence Number: 16587047
• Product Code: FGE
• UDI-Device Identifier: H965105261
• UDI-Public: H965105261
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: H965105261
• Device Lot Number: 0000047450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention