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

Catalog Number A2020-120

Device Problems Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)

Patient Problems Aneurysm (1708); Hematoma (1884); Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the balloon of a 2.0mm x 120mm armada 14 pta balloon catheter ruptured.On removal of the pta balloon catheter, it was noted that balloon material remained within the patient anatomy.The separated balloon material was retrieved.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported balloon rupture and separation was confirmed.The resistance was not confirmed as it was based on case circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The reported patient effects hematoma and pain of are listed in the armada 14 percutaneous transluminal angioplasty (pta) balloon catheter instructions for (ifu) as complications may occur as a result of pta.Based on the information provided and analysis of the returned device, the reported difficulties and subsequent treatment/therapy appear to be due to operational circumstances of the procedure.It is likely that the resistance during advancement and rupture occurred due to interaction with lesion calcification or associated devices causing damage to the outer surface of the balloon.The additional damage stretched/separated portion of the balloon and inner member likely occurred as the ruptured balloon material catching on the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: the procedure was performed to treat a totally occluded lesion in the posterior tibial artery with no tortuosity.The 2.0 x 120 mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion with resistance from the anatomy.Multiple inflations to 8 atmospheres of the balloon were made.Following the balloon rupture, the pta balloon catheter was withdrawn into the 6f sheath and an additional unspecified balloon catheter was advanced parallel to trap the separated balloon material in the sheath.The sheath and balloon catheters were then removed as a single unit.Post procedure, the patient developed a progressive aneurysm and a painful hematoma in the calf.No treatment was performed for the aneurysm as it occluded spontaneously and the hematoma was managed conservatively.No additional information was provided.

• 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: 7803295
• MDR Text Key: 117829194
• Report Number: 2024168-2018-06459
• Device Sequence Number: 1
• Product Code: LIT
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: A2020-120
• Device Lot Number: 8041741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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): Hospitalization; Required Intervention