MAUDE Adverse Event Report: ANGIODYNAMICS MARINER ANGIOGRAPHIC CATHETER

Catalog Number	11733201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.(b)(4).Device unavailable for return.
Event or Problem Description
As reported (b)(6) 2016, a patient presented of unknown age and gender for an angiographic procedure.During the procedure, the catheter tip fractured off the shaft of the catheter.It was reported the catheter was not placed inside of the patient at the time of the fracture.The patient suffered no harm or injury due to the event.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
Additional Manufacturer Narrative
It was reported that the disposable device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of mariner tip break could not be confirmed because the device was not returned for evaluation.A review of the lot history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A root cause for the reported complaint description cannot be determined.The instructions for use (ic 444), 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.It was reported that the fracture occurred outside the patient and the patient was unaffected due to this event.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.(b)(4).

• Brand Name: MARINER ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5762313
• Report Number: 1319211-2016-00096
• Device Sequence Number: 16147555
• Product Code: DQO
• UDI-Device Identifier: H787117332015
• UDI-Public: H787117332015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2016

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
• Operator of Device: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 11733201
• Device Lot Number: 4959805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 07/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1