MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

Catalog Number B1050-060

Device Problems Difficult to Remove (1528); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

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 additional relevant information.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the mid femoral vein that was mildly tortuous, mildly calcified and 80% stenosed. A femoral dilatation was performed with the armada 35 5 x 60 mm percutaneous transluminal angioplasty catheter. After the balloon was fully deflated, it was difficult to move the delivery system over the non-abbott 0. 035 guide wire to remove it from the patient anatomy. There was a lot of resistance but the device was finally removed successfully as a single unit. The proximal part of the balloon was reported to be very narrow and very difficult to slide over the wire. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). The device was returned for analysis. Visual and functional inspections were performed. The reported difficulties were confirmed. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 35 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 7425783
• MDR Text Key: 105419072
• Report Number: 2024168-2018-02720
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2021
• Device Catalogue Number: B1050-060
• Device Lot Number: 71127G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial