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

Model Number	B1120-060
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with 55% stenosis in the right external iliac vein.A 12 x 60mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion for off-label use; however, the balloon ruptured after first inflation at 4 atmospheres.The armada 35 bdc with the ruptured balloon was simply removed from the anatomy.The procedure ended at this point.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A visual inspection was performed on the returned balloon catheter, and 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 incidents and/or complaints reported from this lot.In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.It should be noted that the armada 35 instructions for use (ifu) states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries.In this case, the reported ifu violation of used in the iliac vein did not cause or contribute to the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.In this case, it is likely that during advancement through the anatomy, the outer surface of the balloon became compromised and/or damaged resulting in the reported balloon rupture during the first inflation to 4 atmospheres.The noted scratches at the rupture site also suggests interaction causing damage to the outer surface of the balloon material.The noted balloon folded inward likely occurred post procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11562206
• Report Number: 2024168-2021-02328
• Device Sequence Number: 4150642
• Product Code: LIT
• UDI-Device Identifier: 08717648154997
• UDI-Public: 08717648154997
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 02/28/2023
• Device Model Number: B1120-060
• Device Catalogue Number: B1120-060
• Device Lot Number: 90918G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 63