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

Model Number	B2040-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat an 80% in-stent restenosed lesion in the right superficial femoral artery.A 4.0x200mm armada 35 balloon catheter was prepared per the instructions for use without any issues.The balloon catheter was inflated once at 8 atmospheres; however, the balloon ruptured.The procedure was successfully completed with a new 4.0x200mm armada 35 balloon catheter for balloon angioplasty.There were no adverse patient effects and no 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
• MDR Report Key: 10891196
• Report Number: 2024168-2020-09844
• Device Sequence Number: 11525241
• Product Code: LIT
• UDI-Device Identifier: 08717648155147
• UDI-Public: 08717648155147
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 10/31/2022
• Device Model Number: B2040-200
• Device Catalogue Number: B2040-200
• Device Lot Number: 90515G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR