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

Model Number	B2060-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional two devices referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, heavily calcified right common iliac artery.A 6.0x60mm and a 6.0x40mm armada 35 balloon were attempted to pre-dilate the lesion; however, both balloons reportedly ruptured at 4 atmospheres (atm).Both devices were removed without issue and a 7.0x59mm omnilink stent was implanted and a 9.0x60mm armada's 35 was attempted to post dilate, but ruptured at 6 atm.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible that the balloon rupture occurred due to interaction with the heavily calcified right common iliac artery causing damage to the outer surface of the balloon material; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, heavily calcified right common iliac artery.A 6.0x60mm and a 6.0x40mm armada 35 balloon were attempted to pre-dilate the lesion; however, both balloons reportedly ruptured at 4 atmospheres (atm).Both devices were removed without issue and a 7.0x59mm omnilink stent was implanted and a 9.0x60mm armada's 35 was attempted to post dilate, but ruptured at 6 atm.There was no adverse patient effects and no clinically significant delay.No additional information was provided.Additional information received subsequent to filing the initial report stated all three armada devices ruptured at the first inflation.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
• MDR Report Key: 11886045
• Report Number: 2024168-2021-04414
• Device Sequence Number: 1266221
• Product Code: LIT
• UDI-Device Identifier: 08717648155260
• UDI-Public: 08717648155260
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 11/30/2023
• Device Model Number: B2060-040
• Device Catalogue Number: B2060-040
• Device Lot Number: 00601G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1