MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

Catalog Number 1013469-200

Device Problem Deflation Problem (1149)

Patient Problem Thrombosis (2100)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4) which permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The device was received. Investigation is not yet complete. A follow-up report will be submitted with all. Additional relevant information. Na.

Event Description

It was reported that the procedure was to treat a left superficial femoral artery. A 5. 5x200mm armada 18 otw (over the wire) balloon dilatation catheter (bdc) was advanced to the lesion without issue and inflated once at nominal pressure. During removal, the bdc failed to deflate, several attempts were performed but unsuccessful. After 10 minutes of efforts, the balloon was able to successfully deflate. It was then noted that a clot formation on the lower leg was formed. An atherectomy catheter was used to suck the clot out. Residual clot persisted and tissue plasminogen activator medication was provided to resolve the issue. Hospitalization was prolonged due to this issue. The patient is fine. There was no adverse patient sequela reported. No additional information was provided.

• Brand Name: ARMADA 18 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: connie speck ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8795930
• MDR Text Key: 151219326
• Report Number: 2024168-2019-10099
• Device Sequence Number: 1
• Product Code: LIT
• 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

• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1013469-200
• Device Lot Number: 9011542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• 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: 07/16/2019 Patient Sequence Number: 1