MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number	H787107094025
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Codes	Aortic Dissection (2491); Patient Problem/Medical Problem (2688)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on april 10, 2017: the treating physician reported that during the angiographic procedure, the angiographic catheter seemed difficult to manipulate.While advancing the catheter, the tip of the catheter caused dissection of the artery wall.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.However, photographs were provided by the user.The customer's reported complaint description of the patient experiencing dissection to the artery wall due to stiff catheters is confirmed based on the photos provided by the complainant.A review of the lot history records, obtained via shr, was performed for the 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.Prior to and during the packaging process, the catheters are inspected for damage.It is possible that while advancing the catheter over the guidewire, resistance was met inside the body causing the catheter material to kink.If this did occur and the procedure continued, the rigid kinked edges could cause abrasive destruction while traveling through tortuous veins.Though this cannot be definitively determined, this does not appear to be a result of any manufacturing discrepancies.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 SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6556396
• Report Number: 1319211-2017-00051
• Device Sequence Number: 11035111
• Product Code: DQO
• UDI-Device Identifier: H787107094025
• UDI-Public: H787107094025
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: H787107094025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention