MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SOFT-VU ANGIGRAPHIC CATHETER; ANGIOGRAPHIC CATHETER

Catalog Number 10709007

Device Problems Fracture (1260); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

As reported (b)(6) 2014, a pt of unk age and gender presented for an angiographic procedure.When opening the sterile packaging during preparation for the procedure, it was noted the tip of the angiographic catheter had fractured off.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 pt due to this event as the device did not come into contact with the pt.It was reported the disposable device is not available for return to the mfr for evaluation as it was disposed of by the user.

Manufacturer Narrative

As reported complaint sample was disposed of by the user and not returned, angiodynamics is unable to perform a device evaluation.The reported complaint description could not be confirmed.The root cause for the reported complaint description cannot be determined.Although a root cause cannot be determined, the most likely cause would be handling damage after the device left he manufacturing facility.A review of the lot history records was performed for the reported lot for any deviations.The review confirms that the lots met all material, assembly, and performance specifications.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.

• Brand Name: SOFT-VU ANGIGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3788487
• MDR Text Key: 20699268
• Report Number: 1319211-2014-00041
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Catalogue Number: 10709007
• Device Lot Number: 571827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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