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

Model Number B1050-040

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the left leg with stenosis in the superficial femoral artery and popliteal artery with moderate to high grade calcification the first 5x40mm armada 35 balloon dilation catheter (bdc) was advanced to the target lesion; however the balloon ruptured during the first inflation to 12 atmospheres (atm).The bdc was removed from the patient.Then a second same size armada bdc was also advanced to the target lesion and that balloon also ruptured during the first inflation to 10 atm.Therefore, the second bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported.The procedure was completed with a non-abbott balloon.No additional information was provided.

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 other armada 35 balloon dilation catheter (bdc) is filed under a separate medwatch report number.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.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 complaints appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: the armada balloons were air aspirated outside the of the patient prior to use.During advancement to the target lesion both balloons were noted to advance with difficulty due to the anatomy.The second armada balloon was inflated to 12 (atm).This completed the procedure, no additional balloon dilatation was necessary.No additional information has been provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: 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: 14337575
• MDR Text Key: 291240106
• Report Number: 2024168-2022-05005
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: 08717648154607
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 11217G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 65 KG