MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number A2020-200

Device Problems Material Rupture (1546); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The two armada 18 devices were filed under separate medwatch reports.Evaluation summary: visual and functional inspections and scanning electron microscopy (sem) analysis were performed on the returned device.The physical property issue was not confirmed; however, a balloon rupture was confirmed.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 of the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determine that the balloon rupture was due to circumstances during the procedure.

Event Description

It was reported the complex procedure was to treat a lesion with heavy calcification and restenosis in the left distal superficial femoral artery (sfa).The armada 14 was found defective during unpacking and was not used.Two different armada 18 balloon catheters (4.0/200mm, 4.0/120mm) were advanced to the lesion, but both balloons ruptured at 12 atmospheres (atm).Both catheters met resistance during advancement to the lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.The armada 14 reported as defective prior to use, may have entered the patient based on blood found on the returned device.Return device analysis of the armada 14 revealed a pinhole in the balloon.

• Brand Name: ARMADA 14 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: 5840883
• MDR Text Key: 51485934
• Report Number: 2024168-2016-05109
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155994
• UDI-Public: (01)08717648155994(17)190331(10)5100841
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102705
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: A2020-200
• Device Lot Number: 5100841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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