MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

Catalog Number B2070-120

Device Problem Material Rupture (1546)

Patient Problem Perforation (2001)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4). The device was not returned for analysis. 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 complaints. The reported patient effect of vessel injury, e. G. Dissection, perforation is listed in the armada 35 instructions for use as a complication which may occur as a result of percutaneous transluminal angioplasty. Based on the information provided, the balloon rupture appears to be 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 7. 0x120 mm armada 35 ruptured with the first inflation at 14 atmospheres (rated burst pressure) in the heavily calcified right superficial femoral artery. In the opinion of the physician, the rupture was due to the calcified anatomy. A vessel perforation occurred which was successfully treated with a covered stent. Another same size armada 35 was used to treat the lesion. No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9340984
• MDR Text Key: 166999458
• Report Number: 2024168-2019-13724
• 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

• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: B2070-120
• Device Lot Number: 90220G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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: 11/19/2019 Patient Sequence Number: 1