MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number 10720403

Device Problems Fracture (1260); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

As reported (b)(6) 2015, a patient of unknown age and gender presented for an angiographic procedure.When opening the disposable device's sterile packaging while prepping for the procedure, it was noted the tip of the angiographic catheter had fractured off inside of the packaging.The disposable device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient due to the event as the device did not come into contact with the patient.The disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for the event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for the reported lot for any deviations.The review confirms that the lots met all material, assembly, and performance specifications.

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4570377
• MDR Text Key: 5462996
• Report Number: 1319211-2015-00126
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 10720403
• Device Lot Number: 4716659
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1