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

Catalog Number	H965104231
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
Although no sample will be returned for this event, angiodynamics' supplier of the drainage catheters, (b)(4), will be made aware of this event via a supplier corrective action request (scar).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 was discarded at the hospital.
Additional Manufacturer Narrative
As no lot number was reported, a ship history report (shr) was generated for item number h965104231 in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The shr indicated the reporting customer received two (2) lots of this item number in the six months prior to the procedure date.The device history records for the packaging lots obtained through the ship history report were reviewed 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.A supplier corrective action request (scar) was sent to freudenberg medical, angiodynamics' supplier of the drainage catheter, with a request for a review of their manufacturing records.Their review determined that the device was manufactured in accordance with the device master record.As no sample was returned, a device evaluation was not possible and the root cause of the reported damage was unable to be determined.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.(pr19712).

• 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: 7613606
• Report Number: 1317056-2018-00117
• Device Sequence Number: 1424916
• Product Code: FGE
• UDI-Device Identifier: H965104231
• UDI-Public: H965104231
• 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: H965104231
• Was Device Available for Evaluation?: No
• 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