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

Catalog Number	H787137098015
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: when prepping for an angiographic procedure, it was noted the sterile packaging of the accu-vu catheter was torn, compromising the sterility of the device.The package was set aside and a new of the same device was used to complete the procedure.There was no harm or injury to the patient.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Evaluation of the returned device determined this event does not meet the criteria of an adverse event.Returned for evaluation was one opened accu vu catheter with the packaging pouch.A visual review of returned packaging shows the mylar pouch is torn.The tears are down the center of the pouch from chevron end and along one side of the pouch side.The customer's reported complaint description of the packaging pouch tore the wrong way, was confirmed.The pouch did not open along the seal, and the mylar of the pouch was torn down the middle.A device history records search revealed no quality related issues or manufacturing deficiencies at the time of packaging.Although the exact root cause of the event is unable to be determined, it does not appear to be the result of a manufacturing failure.This is the only complaint reported for this failure mode in this product family for the past 15 months and is deemed an isolated incident.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.Complaint # (b)(4).

• Brand Name: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7907020
• Report Number: 1319211-2018-00102
• Device Sequence Number: 11131091
• Product Code: DQO
• UDI-Device Identifier: H787137098015
• UDI-Public: H787137098015
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 06/30/2021
• Device Catalogue Number: H787137098015
• Device Lot Number: 5354779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1