MAUDE Adverse Event Report: ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number	13709701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics was inable to perform an evaluation of the reported device.As no account identifying information was provided, angiodynamics was unable to obtain any follow up information.The customer's reported complaint description of "catheter broken in half when the power injector was triggered" cannot be confirmed because no product was returned for evaluation.Without receiving a sample to evaluated, a root cause cannot be determined.A review of the lot history records was performed for the reported packaging and component lots 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 instructions for use (ic 444), which is supplied to the end user with this catalog number, contains a statement; "reshaping of catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat".This type of complaint will continue to be monitored for trends.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).
Event or Problem Description
Angiodynamics received fda medwatch reference mw5094777.A risk manager reported that the accu-vu omni flush catheter broken in half when the power injector was triggered.The practitioner was able to safely retrieve the catheter from the femoral artery.No end user identifying information was provided.

• Brand Name: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 10247242
• Report Number: 1319211-2020-00042
• Device Sequence Number: 19606171
• Product Code: DQO
• UDI-Device Identifier: H787137097015
• UDI-Public: H787137097015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 13709701
• Device Lot Number: 5561420
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention