MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number 10722706

Device Problems Fracture (1260); Out-Of-Box Failure (2311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

Received for evaluation was an unopened soft-vu catheter.A visual review of the catheter noted that the tip was fractured inside the pouch.The customer's reported complaint description of soft-vu tip fracture is confirmed.A root cause for this reported complaint description cannot be determined.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.This report was submitted under 1319211-2015-00385 on (b)(4) 2015.Two reports with this same number were submitted on that date, the one with lot 4710611 should have been 1319211-2015-00386.(b)(4).

Event Description

As reported, on (b)(6) 2015, a patient of unknown age and gender presented for an angiographic procedure.During prep for the procedure, before opening the kit, it was noted the tip of the catheter had fractured off the catheter inside of the sterile packaging.The unopened kit was set aside and a new of the same was used to successfully complete the procedure.There was no harm or injury to the patient due to the event.The reported disposable device has been returned to the manufacturer for evaluation.

• 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: 5382799
• MDR Text Key: 36648154
• Report Number: 1319211-2015-00386
• 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: 11/20/2015

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: 01/31/2016
• Device Catalogue Number: 10722706
• Device Lot Number: 4710611
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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