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

Model Number	B2090-080
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 98% stenosed lesion in the left external iliac artery.A 9x100mm absolute pro vascular self-expanding stent system (sess) was implanted without issue.During post-dilatation, while advancing with a 9x80mm armada 35 balloon dilatation catheter (bdc), the physician pushed the edge of the tip of the armada bdc against the implanted absolute pro stent causing resistance between the devices, and the absolute pro sess became stretched.The bdc was removed and replaced with a viatrac 14 plus peripheral balloon dilatation catheter to complete post-dilatation, when the balloon was inflated to 24 atmospheres (atm) and ruptured on the first inflation.The viatrac bdc was removed and the armada bdc was re-inserted to successfully complete the post-dilatation.The stretched absolute sess remains implanted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.In this case, it is likely that during post-dilatation while advancing the armada 35 balloon dilatation catheter (bdc) interaction between the edge of the tip of the armada bdc and the implanted absolute pro stent resulted in resistance between the devices and the reported device caused damage.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.The absolute pro and viatrac devices referenced are filed under separate medwatch report numbers.

• 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: 15263263
• Report Number: 2024168-2022-08963
• Device Sequence Number: 12154189
• Product Code: LIT
• UDI-Device Identifier: 08717648155499
• UDI-Public: 08717648155499
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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 Model Number: B2090-080
• Device Catalogue Number: B2090-080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG