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

Catalog Number	H787107322025
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
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.Complaint # (b)(4).
Event or Problem Description
As reported to angiodynamics on april 16, 2018: during an angiographic procedure, when the angiographic catheter was advanced over the guidewire, the catheter tip fractured off from the catheter shaft.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one soft-vu catheter.The associated guidewire was not returned for evaluation.A visual review of the catheter noted that the tip was damaged also there was damaged at the drainage holes.There was several kinks and damage along the catheter shaft.The hub and strain relief were separated from the catheter.The device met all manufacturing dimensional specifications for this product.During functional testing, a guidewire could not be advanced through the catheter due to the catheter tubing being stretched and twisted throughout catheter shaft.The customer's reported complaint description of the catheter broke in half is confirmed.The site of the fracture occurred at the strain relief and not the tip as reported.Additionally, also there was damage throughout the catheter shaft and the drainage holes.The tip was damaged, but was not brittle.A definitive root cause for the complaint description cannot be determined.A possible contributing factor the customer possibly used an incorrect sized guidewire.The recommended guidewire size is.035".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.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 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 SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7506223
• Report Number: 1319211-2018-00043
• Device Sequence Number: 16648829
• Product Code: DQO
• UDI-Device Identifier: H787107322025
• UDI-Public: H787107322025
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2018

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: 01/31/2021
• Device Catalogue Number: H787107322025
• Device Lot Number: 5289947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1