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

Model Number	B2060-040
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
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 moderately calcified, stenosed lesion in the right superficial femoral artery (sfa).A 6mmx40mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion and inflated once to 3 atmospheres (atm); however, the balloon would not inflate any further.The bdc was removed and re-inserted, this time it inflated to the nominal pressure of 6 atm but would not inflate any further.The bdc was removed, without issue.The experienced scrub tech noted that theballoon was performing as if there was a slow leak or a pin hole.There was no reported adverse patient effect and no clinically significant delays in the procedure.A non-abbott stent was placed, after which a non-abbott balloon was used to post-dilatate and complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported inflation issue and leak were not confirmed.During testing, the balloon fully inflated to rated burst pressure (rbp) of 20 atmospheres min, with no anomalies noted; thus, the reported leak and inflation issue were not 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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported leak and inflation issue.However, possible factors that can contribute to a leak in the system include, but are not limited to, manufacturing, balloon damage during use, inflation technique, interactions with accessory devices, catheter damage, or insufficient preparation prior to use.Additionally, possible factors that may contribute to difficulty inflating may include, but are not limited to, manufacturing, damage to the inflation lumen, patient anatomical morphology and patient disease state.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• 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: 16595070
• Report Number: 2024168-2023-02977
• Device Sequence Number: 11993350
• Product Code: LIT
• UDI-Device Identifier: 08717648155260
• UDI-Public: 08717648155260
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: 10/31/2025
• Device Model Number: B2060-040
• Device Catalogue Number: B2060-040
• Device Lot Number: 20520G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC BALLOON
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG