MAUDE Adverse Event Report: ANGIODYNAMICS EXODUS MULTIPURPOSE DRAINAGE CATHETR; DRAINAGE CATHETER

Catalog Number	H965101511
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this device is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.
Event or Problem Description
As reported by end user hospital, "the patient had a pancreatic pseudo cyst with a drainage catheter in place.The catheter began to leak around the insertion site.On investigation, the catheter was found to be cracked in several places.This resulted in the drain having to be replaced.".
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number ((b)(4)) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.Two lots were obtained.The device history records (dhr) for the lots obtained through the ship history report were reviewed for any deviations related to the reported defect of the complaint.No adverse trends were identified.The (b)(6) 2017 angiodynamics complaint report was reviewed for the for the exodus drainage catheter product family and the failure mode "catheter split." no adverse trends were identified.Drainage catheters are a purchased device from supplier feudenberg medical.No device sample was returned, however a supplier corrective action request (scar) was sent to (b)(6) medical for dhr review of supplier lots.In their reply, feudenberg medical indicated that they could not determine the root cause for this complaint without a device evaluation.Their dhr investigation revealed no deviation of the device specifications.All other records demonstrate the device was manufactured in accordance with the device master records.(b)(4).Device not returned to manufacturer.

• Brand Name: EXODUS MULTIPURPOSE DRAINAGE CATHETR
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5694501
• Report Number: 1317056-2016-00075
• Device Sequence Number: 10781635
• Product Code: FGE
• UDI-Device Identifier: H965101511
• UDI-Public: H965101511
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H965101511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2016
• Supplement Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 22