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

Catalog Number	B2050-040
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superficial femoral artery (rsfa).The 5x40mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and the the balloon was inflated to 12 atmospheres (atm); however, a leak was noted outside the anatomy at the black part of the hub.The leak was noted by a drip of the contrast/saline mixture.The balloon was able to be deflated and removed from the patient without issue.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported leak was not confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported that the contrast mix used in the procedure was 70% saline/ 30% contrast.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35 / armada 35 ll, global, instructions for use (ifu) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.Based on the information reported through the complaint report, a conclusive cause for the reported leak could not be determined.Possible factors that may contribute to a leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, damage to the balloon or loose connections.In this case, a conclusive cause for the reported leak could not be determined since the complaint was not confirmed during analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 medical device problem code 2017: contrast incorrect.
Event or Problem Description
Subsequent to the previously filed report, the initial information was further reviewed and it was noted that a 70/30 contrast ratio was used.No additional information was provided.

• 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: 19233115
• Report Number: 2024168-2024-05398
• Device Sequence Number: 6016104
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: (01)08717648155178(17)250228(10)10910G1
• 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): 06/21/2024

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: 02/28/2025
• Device Catalogue Number: B2050-040
• Device Lot Number: 10910G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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: Unknown