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

Model Number	B2090-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was a procedure to treat a moderately calcified and 70% stenosed iliac artery.An armada 35 9x40 balloon catheter was inserted and the balloon was attempted to be inflated.However, when the balloon was inflated to 6 atmospheres, it was noticed that it as unable to reach nominal pressure due to a leak of the contrast medium.The balloon was able to be removed without issues.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device 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.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information and retuned analysis, it is likely that during advancement through the moderately calcified and 70% stenosed anatomy, the balloon outer surface became damaged resulting in the reported balloon rupture.The noted scratches and peeling near the rupture location also suggest interaction causing damage to the outer surface of the balloon material.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: 10536046
• Report Number: 2024168-2020-07713
• Device Sequence Number: 14404508
• Product Code: LIT
• UDI-Device Identifier: 08717648155475
• UDI-Public: 08717648155475
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 11/30/2022
• Device Model Number: B2090-040
• Device Catalogue Number: B2090-040
• Device Lot Number: 90601G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 70