MAUDE Adverse Event Report: AV-TEMECULA-CT FOX SV PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 83982-02

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during preparation a 6x80mm fox sv percutaneous transluminal angioplasty (pta) catheter was connected to an indeflator and the catheter sidearm (port) was cracked.Air was entering into the catheter.The device was not used and there was no patient involvement.A 6x60mm fox sv pta catheter was used to successfully continue the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported issue related to a leak at the hub due to a cracked side arm.A review of the lot history record revealed one nonconformity related to the reported event.Abbott vasculars review of the complaint handling database identified no similar events for this lot.Root cause analysis concluded that the issue may be related to manufacturing.No corrective action is warranted at this time, as this appear to be a one-time event and does not likely affect a greater population.

• Brand Name: FOX SV PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BERINGEN, SWITZERLAND REG# 9710478; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5943750
• MDR Text Key: 54785999
• Report Number: 2024168-2016-06024
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 83982-02
• Device Lot Number: 851795
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1