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

Model Number B2060-040

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

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 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.

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
• 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: 16595070
• MDR Text Key: 311818357
• Report Number: 2024168-2023-02977
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155260
• UDI-Public: 08717648155260
• 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,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2022
• 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: MEDTRONIC BALLOON
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG