MAUDE Adverse Event Report: ACCUVU SIZING ANGIOGRAPHIC CATHETER

Catalog Number	13709803
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A distributor reported an issue with an angiographic catheter while preparing for a procedure.During assembly with the guidewire, the catheter tip broke into several pieces.The procedure was completed with a different device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated that the reported device is not available to be returned 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, the end user provided a photo of the fractured device.The photo showed the catheter tip fractured in two pieces.The customer's reported complaint description of "tip broke into several pieces' was confirmed as the customer provided a photo.No sample was returned for evaluation.Without receiving sample for evaluation a root cause 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.Labeling review: 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.Reference (b)(4).

• Brand Name: ACCUVU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: ACCUVU SIZING ANGIOGRAPHIC CATHETER
• MDR Report Key: 10731846
• Report Number: 1319211-2020-00069
• Device Sequence Number: 16619943
• Product Code: DQO
• UDI-Device Identifier: H787137098035
• UDI-Public: H787137098035
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: No Information
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 13709803
• Device Lot Number: 5278662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/24/2020
• Supplement Report FDA Received Date: 10/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR