MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

Catalog Number A2040-080

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2016

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 the procedure was to treat a lesion located in the left superficial femoral artery that was non tortuous, mildly calcified and 90% stenosed. The armada 14 pta catheter was being used for pre-dilatation, and during angiography, it was observed that the proximal edge of the proximal marker was located 5-8mm distal to the proximal shoulder into the balloon working length. Despite this being observed, the armada 14 balloon catheter was continuously used and inflated in the lesion at 10 atmospheres. There was no resistance during advancement to the lesion. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported mislocated balloon markers were not confirmed. The investigation was unable to determine a conclusive cause for the reported difficulty. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 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): CLONMEL, IRELAND REG# 9616693; 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: 6011625
• MDR Text Key: 57270621
• Report Number: 2024168-2016-06757
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: HEALTH PROFESSIONAL
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/07/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 02/28/2019
• Device Catalogue Number: A2040-080
• Device LOT Number: 5090941
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 10/05/2016
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 10/07/2016 Patient Sequence Number: 1

Treatment

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