MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1013468-100

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The guide wire is being filed under a separate medwatch report.Evaluation summary: visual and functional inspections were performed on the returned devices the reported difficulties were confirmed.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 of the reported lot revealed no other incidents.The investigation determined the difficulties were likely due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately tortuous and moderately calcified left superficial femoral artery.A 5.0 x 100 mm armada 18 balloon dilatation catheter (bdc) was used; however, it met resistance with a 4.0 x 300 cm steelcore guide wire when the bdc was advancing over the guide wire.Positioning was lost; therefore, both devices were removed as a single unit and another unspecified bdc and a guide wire were used to successfully complete the procedure.There was resistance between the armada bdc and the guide wire during removal.There was a delay in the procedure but it was not clinically significant, and there were no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 18 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: 7340072
• MDR Text Key: 102591053
• Report Number: 2024168-2018-01845
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: 08717648208201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• 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
• Report Date: 03/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 1013468-100
• Device Lot Number: 7040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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
• Patient Age: 51 YR
• Patient Weight: 82