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

Catalog Number B2060-100

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 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). A visual inspection was performed. The reported balloon rupture and balloon/inner member separations were confirmed. The reported difficult to remove from the introducer sheath could not be performed due to the device condition. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported balloon rupture. The difficulty removing the device from the sheath and subsequent balloon/inner member/marker separations, inner member damages appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical devices: guide wire: 0. 035 terumo guidewire, sheath: ab medica 6f 45cm. 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 located in the mid-superficial femoral artery that was mildly tortuous and heavily calcified. The armada 35 6 mm / 100 mm balloon ruptured during the first inflation at 10 atmospheres. During removal back through the 6f sheath, there was strong resistance and when force was applied, the balloon separated in two pieces proximally in the sheath. The hub of the sheath was opened and the separated portion of the balloon was removed. The proximal part was simply withdrawn. The distal part was simply collected from the sheath using tweezers. Another armada was used to complete the procedure. The device was prepped according to the instructions for use. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.

• 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: 7183453
• MDR Text Key: 163667250
• Report Number: 2024168-2018-00297
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/22/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2020
• Device Catalogue Number: B2060-100
• Device Lot Number: 70302G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial