MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number 10709003

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

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

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

Returned for evaluation was a 5f soft-vu catheter.A visual evaluation of the returned device noted the tip of the catheter was fractured.Based on the evaluation of the returned sample, this complaint meets the criteria of a reportable event.As the returned device was fractured, the customer's reported complaint description of soft-vu catheter kinked is not confirmed.A root cause for the reported complaint description cannot be definitively determined.A review of the lot history records was performed 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, 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.

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4782194
• MDR Text Key: 16544774
• Report Number: 1319211-2015-00277
• 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: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 10709003
• Device Lot Number: 4820792
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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