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

Model Number	B2140-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
User facility medwatch report (4500440000-2022-8030) received stating: the surgeon performed another intravascular ultrasound, which showed some evidence of incomplete expansion at the most proximal aspect of the abre stent at the inferior vena cava notch and some level of luminal loss.To address this problem, the surgeon then advanced with the 12 armada balloons from both femoral vein access and ballooned the most proximal aspect using the kissing balloon technique to gain a good wall apposition and expansion of the abre stent at its proximal extent.What was the original intended procedure? : bilateral iliocaval reconstruction.What problem did the user have (check all that apply) : device failed (e.G.Broke, couldn't get it work or stopped working).No additional information was provided.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: medwatch report# 4500440000-2022-8030.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Device available for eval changed from ni to no.
Event or Problem Description
User facility medwatch report (4500440000-2022-8030) received stating: the surgeon performed another intravascular ultrasound, which showed some evidence of incomplete expansion at the most proximal aspect of the abre stent at the inferior vena cava notch and some level of luminal loss.To address this problem, the surgeon then advanced with the 12 armada balloons from both femoral vein access and ballooned the most proximal aspect using the kissing balloon technique to gain a good wall apposition and expansion of the abre stent at its proximal extent.What was the original intended procedure? : bilateral iliocaval reconstruction what problem did the user have (check all that apply) : device failed (e.G.Broke, couldn't get it work or stopped working) subsequent to the initially filed report, the following information was provided: the patient presented with inferior vena cava occlusion, bilateral iliac vein occlusion, chronic venous insufficiency and clinical, etiologic, anatomic and pathophysiologic (ceap) classification 4 of skin changes assigned to venous disease.The 14x80mm armada 35 balloon dilatation catheter (bdc) ruptured.The bdc was prepared (air aspiration) outside the anatomy prior to use, without any issues.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.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
• 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: 15244355
• Report Number: 2024168-2022-08850
• Device Sequence Number: 6456521
• Product Code: LIT
• UDI-Device Identifier: 08717648155611
• UDI-Public: 08717648155611
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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 Expiration Date: 11/30/2024
• Device Model Number: B2140-080
• Device Catalogue Number: B2140-080
• Device Lot Number: 10609G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABRE STENT
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 105 KG