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

Catalog Number	B2040-120
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Device code 2017 - incorrect prep.The device is expected to be returned for investigation.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 the procedure was performed to treat a moderately calcified, mildly tortuous popliteal artery that was 91% stenosed.A 4.0x120 armada 35 balloon dilatation catheter (bdc) leaked from the inflation port while inflating the balloon.Reportedly, the armada 35 was not prepped (air aspirated) prior to use.A new 4.0x80mm armada bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The leak was not confirmed.However, a 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 of the reported lot revealed no other incidents.The armada 35 instruction for use (ifu) describes preparation of the pta catheter prior to insertion into the anatomy.The investigation determined that the balloon rupture likely occurred due to case circumstances.It is likely that the rupture occurred due to interaction with lesion calcification which was described as moderately calcified, mildly tortuous popliteal artery that was 91% stenosed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Additional information: device analysis did not confirm the leak from the hub and noted leakage from the balloon.It was confirmed from the account that the rupture occurred during the procedure.The balloon ruptured at 3atms on the first inflation.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: 8970098
• Report Number: 2024168-2019-11531
• Device Sequence Number: 14097190
• Product Code: LIT
• UDI-Device Identifier: 08717648155123
• UDI-Public: 08717648155123
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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 Catalogue Number: B2040-120
• Device Lot Number: 80616G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1