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

Catalog Number 1014260-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Vasoconstriction (2126)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the armada 18 instructions for use (ifu) as a known patient effect.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that during a procedure of the non-tortuous, non-calcified, de novo, mid tibial artery, while the armada 18 balloon was inflated, the patients leg moved vigorously and a vessel spasm occurred.Post ballooning a vessel rupture was noted.The armada balloon was re-inflated for 2 minutes as treatment with a good outcome.There was no reported adverse patient sequela or a clinically significant delay in the procedure.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: 6842056
• MDR Text Key: 84700003
• Report Number: 2024168-2017-07286
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1014260-100
• Device Lot Number: 6040541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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
• Treatment: SHEATH: 6FR
• Patient Outcome(s): Required Intervention
• Patient Weight: 55