MAUDE Adverse Event Report: ANGIODYNAMICS, INC. MARINER ANGIOGRAPHIC CATHETER

Catalog Number 11732701

Device Problems Bent (1059); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

As reported (b)(6) 2015, when unpacking the received device at the medical facility, it was noted the tip of the angiographic catheter was bent and appeared to be slightly fractured.As the defect was noted during unpacking, the reported device did not come into contact with a pt or a sterile medical setting.It was reported the disposable device us available for return to the mfr for eval.

Manufacturer Narrative

The reported defective device is available for return to the mfr for a device eval.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for event is currently in progress.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 specs.The results of the device eval will be sent via a follow up medwatch.

• Brand Name: MARINER 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: 4707917
• MDR Text Key: 5665579
• Report Number: 1319211-2015-00241
• 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: 03/30/2015

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: 09/30/2017
• Device Catalogue Number: 11732701
• Device Lot Number: 4807197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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