MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number	H787107323015
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event 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 (b)(6) 2017: when opening the sterile packaging during prep for an angiographic procedure it was noted the tip of the angiographic catheter had fractured off inside of the packaging.The device was set aside and a new of the same device was used to complete the procedure.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one soft-vu catheter.A visual review of the catheter noted that the tip was fractured,.3cm from the weld joint.The customer's reported complaint description of soft-vu tip fracture is confirmed.The defect was discovered prior to making patient contact.Although the complaint description is confirmed, a root cause for the defect 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".Capa (b)(4) was initiated to determine the root cause and implement a corrective / preventative action for this type failure.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.Complaint # (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: 6384549
• Report Number: 1319211-2017-00029
• Device Sequence Number: 797800
• Product Code: DQO
• UDI-Device Identifier: H787107323015
• UDI-Public: H787107323015
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K032376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

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 Expiration Date: 10/31/2017
• Device Catalogue Number: H787107323015
• Device Lot Number: 4818806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1