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

Catalog Number B1140-040

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.Obtaining the device may have further aided the analysis.The investigation was unable to determine a conclusive cause for the reported difficulties.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 reported from this lot.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 procedure was to treat the subclavian vein.After successful pre-dilatation, and during removal, the armada 35 14 mm / 40 mm on 80 cm balloon dilatation catheter balloon got stuck inside a stent in the basilica vein and a piece of the balloon came off.There was a reported delay as a cut down procedure was needed to remove the separated piece of the balloon, however it was not clinically significant as there were no adverse patient effects.The device was prepped according to the instructions for use.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: 6552951
• MDR Text Key: 74697528
• Report Number: 2024168-2017-04005
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155024
• UDI-Public: (01)08717648155024(17)200430(10)61102G1
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: B1140-040
• Device Lot Number: 61102G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Patient Outcome(s): Required Intervention