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

Model Number	B2060-250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.Based on the information provided, a conclusive cause for the balloon ruptures could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superior femoral artery (sfa).The 6.0x250mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance to the lesion.During the first inflation, the balloon ruptured at 8 atmospheres (atm).The bdc was removed without issue, and the procedure completed with another device.There was no clinically significant delay in the procedure, and no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 35 OTW LL
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10593875
• Report Number: 2024168-2020-08059
• Device Sequence Number: 1282413
• Product Code: LIT
• UDI-Device Identifier: 08717648155338
• UDI-Public: 08717648155338
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 04/30/2023
• Device Model Number: B2060-250
• Device Catalogue Number: B2060-250
• Device Lot Number: 91127G2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 95