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

Catalog Number	H965101511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Angiodynamics' supplier of the drainage catheters, (b)(4), will be made aware of this event via a supplier corrective action request (scar) and will be provided with the returned device for evaluation.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).
Event or Problem Description
As reported, exodus drainage catheter in place for "a few days" and connected to an accordion suction drain.The catheter hub cracked and was removed and replaced.There was no patient injury or complications.The used catheter has been returned to angiodynamics.
Additional Manufacturer Narrative
A review of the device history records (dhr) was performed for the reported packaging lot 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 recent angiodynamics complaint report was reviewed for the drainage catheters product family and the failure mode "hub cracked." no adverse trend was identified.The returned device sample, along with a supplier corrective action request (scar) was sent to freudenberg medical, angiodynamics' supplier of the drainage catheter.Their review stated that the full catheter sample was not returned: the catheter had been cut in half with only the proximal portion of the luer/hub assembly being returned.The knob was unlocked and locked again.During locking the audible "click" was heard on the sample.Visual examination confirmed that the hub body was cracked opposite of the parting line location.They indicated that the complaint is not manufacturing attributable.Potential causes of hub cracking at the end user hospital 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.Review of the dhr indicates that the device was manufactured in accordance with the device master record.(pr19710).

• Brand Name: ANGIODYNAMICS / EXODUS
• Common Device Name: MULTIPURPOSE DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7613603
• Report Number: 1317056-2018-00115
• Device Sequence Number: 13891772
• Product Code: FGE
• UDI-Device Identifier: H965101511
• UDI-Public: H965101511
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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 Catalogue Number: H965101511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1