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

Catalog Number B1090-060

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). 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 lesion in the right brachial artery. A 9x60mm armada 35 balloon catheter was prepped per the instructions for use. The balloon catheter was advanced to the lesion; however, the balloon ruptured and separated during first inflation at 12 atmospheres. Resistance removing the device off the guide wire was felt. The procedure was successfully completed with a new 9x60mm armada 35 balloon catheter. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.

Manufacturer Narrative

(b)(4). Visual inspection and scanning electron microscopy (sem) analysis was performed on the returned device. The reported balloon rupture, difficulty removing from the guide wire and separation were confirmed. The investigation determined the reported difficulties were likely due to case circumstances. 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 similar incidents from this lot. The investigation determined the reported 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.

• 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: 6491277
• Report Number: 2024168-2017-03161
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Catalogue Number: B1090-060
• Device Lot Number: 51120G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial