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

Catalog Number	H965101511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no used device was returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
Exodus drainage catheter placed on (b)(6)2017 for pelvic abscess.Hub of catheter cracked while patient was at home, requiring catheter to be removed and replaced on (b)(6) 2017.No complications or serious injury to patient was reported.
Additional Manufacturer Narrative
A review of the device history records (dhr) was performed for the reported packaging lot (0000045454) for item number h965101511 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 january 2017 angiodynamics complaint report was reviewed for the drainage catheter product family and the failure mode, "hub cracked." no adverse trend was identified.The end user's reported complaint of cracks at or the near the hub cannot be confirmed since no product was returned for evaluation.Angiodynamics purchases the drainage catheters from (b)(4).They were sent a supplier corrective action request (scar) for a review of their manufacturing records.The dhr investigation revealed no deviation of the device specifications.((b)(4)).Device not returned to manufacturer.

• Brand Name: ANGIODYNAMICS / EXODUS
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6365402
• Report Number: 1317056-2017-00011
• Device Sequence Number: 16278627
• Product Code: FGE
• UDI-Device Identifier: H965101511
• UDI-Public: H965101511
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K093392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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: Patient Family Member or Friend
• Device Catalogue Number: H965101511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR