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

Catalog Number B2080-060

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

H6: medical device problem code 2017 - incorrect removal.H6: medical device problem code 2017 - contrast incorrect.H6: medical device problem code 2017 - against resistance.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the proximal superficial femoral artery (sfa) with heavy calcification.The stealth atherectomy device was used, however the device got stuck during removal.The device was removed intact and was replaced with a new stealth device.The second stealth device also got stuck during removal.The device was removed intact.The 8.0x60mm armada balloon dilatation catheter (bdc) was prepared (air aspiration) outside the anatomy prior to use and contrast mix was 75/25.The bdc was advanced and resistance was felt during advancement due to calcification.The balloon catheter was pushed a little harder and the catheter crossed.The balloon was inflated twice to 6atm for approximately one minute and negative was held for 30 seconds, but the balloon only partially deflated.The bdc was removed with some resistance and light force was applied; however, the balloon separated in the anatomy.The patient was bleeding, a perforation occurred.The patient went for open surgery for removal of the balloon and to treat the perforation.The separated portion of the balloon was removed from the anatomy.There was no adverse patient sequelae and there was 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: 18827172
• MDR Text Key: 336849665
• Report Number: 2024168-2024-02685
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155444
• UDI-Public: 08717648155444
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B2080-060
• Device Lot Number: 30314G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Treatment: TERUMO SHEATH
• Patient Outcome(s): Required Intervention