MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number	10732301
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2016
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 june 09, 2016, a patient presented of unknown age and gender for an angiographic procedure.At the start of the procedure, when the guidewire was fed through the catheter, the radiopaque part of the catheter fractured off.The 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 this 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
As the reported defective disposable device was not returned, angiodynamics is unable to perform a device evaluation.However, the user did provide a photograph illustrating the defect.Based on the photographic evidence provided by the account, the customer's reported complaint description of soft-vu tip fracture is confirmed.The patient was unaffected due to this failure as this defect was found during preparation.Although the complaint description is confirmed a definitive root cause for the event cannot be determined.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.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." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5762322
• Report Number: 1319211-2016-00097
• Device Sequence Number: 13614667
• Product Code: DQO
• UDI-Device Identifier: H787107323015
• UDI-Public: H787107323015
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K032376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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 Catalogue Number: 10732301
• Device Lot Number: 602905
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1