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

Catalog Number 10732301

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

As reported (b)(4) 2014, a patient of unknown age and gender presented for an angiographic procedure.During prep for the procedure, when opening the sterile packaging, it was noted the tip of the catheter was fractured of the catheter sheath inside of the package.The device was set aside, and a new of the same device was used to complete the procedure.The patient suffered no harm or injury due to the event.It was reported the device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.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.(b)(4).

• Brand Name: SOFT-VU ANGIOGRAPHIC 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: 3905038
• MDR Text Key: 4430131
• Report Number: 1319211-2014-00077
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K914199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2014

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: 05/31/2016
• Device Catalogue Number: 10732301
• Device Lot Number: 596673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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