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

Catalog Number	B2080-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous right common iliac artery.The 8.0x80mm armada 35 balloon dilatation catheter (bdc) ruptured before nominal pressure.There was no adverse patient effects reported and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material rupture.Factors that may contribute to material rupture include, but are not limited to, inadequate balloon integrity, interaction with challenging anatomy, interaction with accessory devices, damage to the balloon, and/or inflating above the rated burst pressure.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D4 - lot number updated.H3 - device returning status updated from yes to no.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material rupture was confirmed.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported material rupture appears to be related to the operational context of the procedure.It was reported that the balloon ruptured during inflation within the anatomy.Analysis of the returned balloon catheter confirmed the reported material rupture as a pinhole on the balloon.This type of damage can occur when the balloon interacts with challenging anatomy or an accessory device.In this case, there was no damage or anomalies noted to the balloon during the inspection prior to use or during preparation for use which suggests the damage likely occurred during use.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9 - device available for evaluation updated to yes.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: 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: 17812812
• Report Number: 2024168-2023-10533
• Device Sequence Number: 6954009
• Product Code: LIT
• UDI-Device Identifier: 08717648155451
• UDI-Public: (01)08717648155451(17)250131(10)10824G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: B2080-080
• Device Lot Number: 10824G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 05/21/2024; 06/04/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 05/22/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female