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

Model Number	B2080-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
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 8x40mm armada 35 balloon mentioned will be filed under a different medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 90% lesion in the right external iliac artery.Atherectomy was performed and an 8x40mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and inflated one time; however, it ruptured at burst pressure.Subsequently, an 8x60mm armada 35 bdc was advanced and inflated one time to nominal pressure when the balloon ruptured and separated from the catheter in the right external iliac artery.One hour was spent trying to snare out the separated segment, however it was unsuccessful.An 8.X5cm non-abbott covered stent was implanted to embed the separated segment in the artery.There was no adverse patient sequela.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 incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.The subsequent treatment appears to be related to the operational context of the procedure.In this case, it is possible that the balloon dilatation catheter (bdc) may have interacted with the patient¿s moderately calcified, mildly tortuous, and 90% stenosed lesion or an accessory device during advancement, contributing to the reported material rupture, material separation, and subsequent difficult to remove; however, because the device was not returned, this cannot be confirmed.Additionally, it was reported that the separated portion of the bdc was embedded into an artery with a stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3: device was not available for evaluation.

• 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: 15491867
• Report Number: 2024168-2022-10032
• Device Sequence Number: 11242493
• Product Code: LIT
• UDI-Device Identifier: 08717648155444
• UDI-Public: 08717648155444
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 11/16/2022

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 Expiration Date: 06/30/2023
• Device Model Number: B2080-060
• Device Catalogue Number: B2080-060
• Device Lot Number: 00121G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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: VIABHAN STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male