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

Catalog Number	H965105261
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot (0000047450) for item number h965105261 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 october 2018 angiodynamics complaint report was reviewed for the exodus drainage catheter product family and the failure mode "hub cracked." no adverse trend was indicated.Without receiving product for evaluation, we are unable to definitively determine a root cause for the reported event.Potential causes of hub cracking include: cross-threading of the mating luer as the device is attached, over-tightening during initial installation resulting in an immediate crack, over-tightening during installation resulting in a longer-term stress crack due to an oversize mating luer taper, and environmental stress cracks driven by a chemical that the catheter has been exposed to during installation or use.The drainage catheter component is supplied to angiodynamics by the supplier (b)(4).(b)(4) has been notified via a scar (supplier corrective action request) for informational purposes only.(b)(4).
Event or Problem Description
As reported, patient with an exodus drainage catheter required it to be replaced on (b)(6) 2018 due to a cracked hub.The used catheter was discarded at the hospital.No patient complications were reported.

• 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: 8088773
• Report Number: 1317056-2018-00210
• Device Sequence Number: 1326722
• Product Code: FGE
• UDI-Device Identifier: H965105261
• UDI-Public: H965105261
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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 Expiration Date: 11/30/2019
• Device Catalogue Number: H965105261
• Device Lot Number: 0047450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1