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

Model Number	B2060-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The 5x100mm armada 35 and the 2x200mm armada 14 referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the patient presented with an acute myocardial infarction (mi).The procedure was to treat a heavily calcified, mildly tortuous, 90% stenosed, de novo lesion in the lesion in the right superior femoral artery (sfa).A 5.0x100mm on 135cm armada 35 balloon dilatation catheter (bdc) balloon was advanced to the lesion but ruptured before reaching nominal pressure during the first inflation.A 5.0x150mm 135cm armada 35 bdc was used to continue the procedure.A 6.0x200mm on 135cm armada 35 bdc balloon was advanced to the lesion but ruptured before reaching nominal pressure during the first inflation.A 6.0x100mm 150cm non-abbott device was used to continue the procedure.A 2.0x200mm on 150cm armada 14 bdc was advanced, but the balloon tip and distal shaft became stuck in the vessel while pulling back the balloon and separated.The plan was to schedule a retrieval of the separated device that remained in the patient, the next day, but due to cath lab availability, it was postponed one more day.The patient passed away on the second day after the angioplasty procedure due to the effects of the mi.In the physician's opinion, the death and mi, were not related to any of the abbott devices.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was 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 determined the reported balloon rupture appears to be related to operational context.It was reported by the account that per the physician opinion, the armada 35, did not cause or contribute to the patient's death in any way.The reported patient effect of death is listed in the percutaneous transluminal angioplasty (pta), armada 35 / armada 35 ll, global, instructions for use as a known patient effect.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 16440452
• Report Number: 2024168-2023-01914
• Device Sequence Number: 14252793
• Product Code: LIT
• UDI-Device Identifier: 08717648155321
• UDI-Public: 08717648155321
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 03/31/2025
• Device Model Number: B2060-200
• Device Catalogue Number: B2060-200
• Device Lot Number: 11029G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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