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

Model Number	B1120-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Serious Injury
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 indication to suggest a lot specific product quality issue.Based on the information provided, it is likely that the reported resistance during advancement resulting in failure to cross and balloon rupture was the result of interaction with the challenging anatomy.Additionally, it is likely that during removal, the ruptured balloon material caught on the introducer sheath and separated.The surgical procedure to remove the separated portion of the balloon was related to circumstances of the procedure.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 de novo lesion in the anastomotic part of right pulmonary artery.The 12x40mm armada 35 balloon dilatation catheter (bdc) was advanced over a 0.035¿ non-abbott guide wire for dilatation.The bdc met resistance with anatomy and failed to cross.The bdc was removed and the guide wire was replaced with a non-abbott stiff guide wire.The balloon was slightly re-shaped to a banana shape due to the stenosis and tortuosity of the target lesion before being re-advanced.The bdc reached the target lesion; however, the balloon ruptured during second inflation at an unspecified pressure but below the rated burst pressure.During removal of the bdc, resistance with the introducer sheath was felt and the balloon part separated from the shaft.A cut-down procedure was performed to successfully remove the separated portion.There was no adverse patient sequela reported and no significant delay in the procedure reported.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: 9998171
• Report Number: 2024168-2020-03900
• Device Sequence Number: 4355965
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 90628G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention