MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013468-100
Medical Device Problem Codes	Entrapment of Device (1212); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The electronic lot history record (elhr) 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.The investigation was unable to determine a conclusive cause for the reported leak; however, the reported entrapment of device and surgical intervention appear to be related to circumstances of the procedure.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, it may be possible that the sidearm and or inflation port within the sidearm was damaged; however, without having the device to examine, a conclusive cause could not be determined.Furthermore, it was reported that the balloon dilatation catheter (bdc) interacted with the previously implanted stent such that they became stuck.Additional treatment with cut-down surgery was performed to remove the bdc.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional armada 18 device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat an 100% stenosed lesion in left superficial femoral artery (sfa) and popliteal artery.For post dilatation a 5x200mm armada 18 balloon dilatation catheter (bdc) was used; however, the balloon ruptured after 3 inflations at 8 atmospheres.Therefore, the bdc was removed from the patient without issue.Another same size armada 18 bdc was then used to continue post dilation; however, during the first inflation the second armada balloon was noted to have a leak of contrast at the base of the inflation port.During removal, the second bdc became stuck with the stent that had been implanted and could not be removed from the patient.Therefore, cut-down surgery was performed to remove the bdc.There was no adverse patient sequela.No additional information was provided.

• Brand Name: ARMADA 18 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19325958
• Report Number: 2024168-2024-05934
• Device Sequence Number: 6680514
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: (01)08717648208201(17)240731(10)1021541
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 1013468-100
• Device Lot Number: 1021541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male