MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOOPTIC ANGIOGRAPHIC CATHETER

Catalog Number H787106322015

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2018

Event Type  malfunction  

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 Description

As reported to angiodynamics on march 13, 2018: during an angiographic procedure, when threading the catheter over the guidewire, it was noted the tip of the catheter had cracked.There was no report of any patient harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was one angiographic catheter, p/n: 10632201.Lot number 5275911.A visual examination of the returned device noted two kinks in the catheter shaft.It was also noted the tip of the catheter was damaged/fractured 4.2cm from the tip end.The returned device met all manufacturing dimensional specifications for this product.The customer's reported complaint description of the catheter tip being cracked/fractured is confirmed.Although the complaint description is confirmed, a definitive root cause cannot be determined.However, it does not appear to be manufacturing related.The instructions for use, which is supplied to the end user with states; "tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.Reshaping of the catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat.Never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both." the label indicates a recommended guidewire size of.035".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.Manufacturing personnel are directed to 100% visually inspect this product to verify there are no pin holes or cuts to the packaging, and there is no component damage.This type of defect would be noticed prior to shipment.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: ANGIOOPTIC ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOOPTIC ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7411794
• MDR Text Key: 105384222
• Report Number: 1319211-2018-00033
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787106322015
• UDI-Public: H787106322015
• Combination Product (y/n): N
• PMA/PMN Number: K112452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: H787106322015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1