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

Model Number B1070-040

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular 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.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the heavily calcified lesion, the balloon surface became damaged and/or compromised resulting in the reported balloon rupture.The balloon rupture did not properly refold causing the difficulty to remove from the introducer sheath.Manipulation against resistance resulted in the balloon separation.The reported patient effect of hemorrhage is listed in the armada 35 percutaneous transluminal angioplasty catheter instructions for use, as a known patient effect of the procedure.A conclusive cause for the reported patient effect(s), of hemorrhage and the relationship to the product, if any, cannot be determined.However, the reported treatments appear to be related to the operational context of the procedure as a surgical cut down was performed to access the artery and a suture was used to close the access site.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional armada device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a primitive iliac artery using retrograde approach.There was heavy calcification in the femoral and iliac arteries.A 7.0x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated at 12 atmospheres and ruptured.During removal, there was resistance, the introducer needed to be removed, and the balloon tore into several pieces.A second, same size, armada 35 pta catheter was used and had the same issue and ruptured between 10-12 atm.Another unspecified balloon was used to complete the procedure; however, the patient had bleeding during removal of the introducer and there is a possibility that balloon material was left in the anatomy.A surgical cut down was performed to access the artery and a suture was used to close the access site.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: 10260564
• MDR Text Key: 198531107
• Report Number: 2024168-2020-05675
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: 08717648154782
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 00226G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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