MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	A2025-200
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the right posterior tibial artery with 100% stenosis.The right popliteal artery was recanalized with an unspecified.035 guide wire and then a 5x150 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated to nominal pressure for 120 seconds with restoration of antegrade blood flow.Then, recanalization of the occlusion of the posterior tibial artery was performed with a command 14 guide wire and then the 2.5x200 mm armada 14 pta catheter was inflated and angioplasty performed along the entire length of the lesion.The armada 14 pta catheter was inflated 3 times (10 atm, 14 atm and 20 atm); however, the balloon could not be deflated.Negative pressure was held for 30 seconds and there were multiple attempts to deflate the balloon without success.The balloon was punctured with an additional command 14 guide wire and the balloon was deflated and removed.Further balloon angioplasty was performed with another 2.5x200 mm armada 14 pta catheter.There were no adverse patient sequela.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.H6- medical device problem code 2017 clarifier: above rbp.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.Based on the information provided, a definitive cause for the reported failure to deflate could not be determined.Possible factors that may contribute to failure to deflate include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, a conclusive cause for the reported failure to deflate cannot be determined since the device was not returned for analysis.It was reported by the account that the balloon dilatation catheter (bdc) was inflated 3 times (10 atm, 14 atm and 20 atm).It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 14, global instructions for use (ifu) states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.The rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: device available for evaluation corrected from ¿yes¿ to ¿no¿.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20759610
• Report Number: 2024168-2024-13877
• Device Sequence Number: 8587294
• Product Code: DQY
• UDI-Device Identifier: 08717648156052
• UDI-Public: (01)08717648156052(17)270531(10)3122041
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K102705
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Model Number: A2025-200
• Device Catalogue Number: A2025-200
• Device Lot Number: 3122041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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: COMMAND 14 GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown