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

Model Number	B1140-060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
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 of the reported lot revealed no other complaints.Based on the information provided, a conclusive cause for the balloon ruptures could not be determined.It may be possible that the rupture occurred due to interaction with lesion calcification or associated devices; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional armada device referenced in b5 is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right common iliac vein.A non-abbott stent was implanted.Then one 14 x 60 mm armada 35 and one 14 x 40 mm armada 35 balloon dilatation catheters (bdc) were advanced simultaneously through two different access sites for post-dilatation.However, both balloons ruptured at 6 atmospheres during the first inflation.Both armada bdc devices were simply removed.The procedure ended at this point.The patient is stable.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: 9664277
• Report Number: 2024168-2020-01159
• Device Sequence Number: 16836099
• Product Code: LIT
• UDI-Device Identifier: 08717648155031
• UDI-Public: 08717648155031
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/04/2020

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: 11/30/2021
• Device Model Number: B1140-060
• Device Catalogue Number: B1140-060
• Device Lot Number: 80622G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1