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

Catalog Number B2040-020

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.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 and/or complaints from this lot.Based on the information provided, a conclusive cause for the reported leak could not be determined.It may be possible that the inflation device was not properly connected to the sidearm; however, without having the device to examine, a conclusive cause could not be determined.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 during preparation, air aspiration, of a 4.0 x 20 mm armada 35 balloon catheter an air leak was noted.The balloon catheter was not used and there was no patient involvement.The procedure was successfully completed with an unspecified armada balloon catheter.There were no adverse patient effects and no 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): 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: 9014129
• MDR Text Key: 158132440
• Report Number: 2024168-2019-11761
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155079
• UDI-Public: 08717648155079
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: B2040-020
• Device Lot Number: 70508G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• 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