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	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this event is still being conducted.As the drainage catheter is a purchased device for angiodynamics, we will be sending the returned sample, as well as a supplier corrective action request (scar) to our supplier, (b)(4).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 fluid collection in the right gluteal.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 for item number (b)(4) 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 (b)(6) 2017 angiodynamics complaint report was reviewed for the drainage catheter product family and the failure mode "hub cracked." no adverse trends were identified.As angiodynamics purchases the drainage catheter from (b)(6), the sample was forwarded to them for evaluation, along with a supplier corrective action request (scar).(b)(6) response indicated that they investigated the following manufacturing sources: molding parameters and mold fill analysis, hub body incoming inspection records, and there was no evidence that either would have contributed to the hub cracking.They do not consider the complaint to be manufacturing attributable, and suggest that potential sources of the cracking may be cross-threading of the mating luer when the device is attached, over-tightening during installation, or environmental stress cracks due to a chemical to which the catheter has been exposed during installation or use.Their dhr review revealed no deviations of the device specifications.(b)(4).

• 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: 6365486
• Report Number: 1317056-2017-00012
• Device Sequence Number: 18841718
• 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
• Device Lot Number: 0000045454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• 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: 28 YR