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

Model Number	B1070-020
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
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.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in a heavily calcified and mildly tortuous superficial femoral artery.A 7.0 x 20 mm armada 35 balloon catheter was used to post-dilate (past its rated burst pressure) an unspecified self-expanding stent as it was stenosed.The pressure/atmospheres was reportedly unknown.The balloon ruptured and it was then not possible to withdraw the device into the introducer sheath during removal.Therefore, a cut-down procedure was performed to remove both the device and the introducer sheath.The femoral artery was then surgically closed.There was no adverse patient sequela reported.No additional information was provided.
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 incidents.It was reported that the balloon ruptured above the rated burst pressure (rbp); however, the exact pressure was not reported.It should be noted that the armada 35 instructions for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.Based on the information provided, a conclusive cause for the balloon rupture could not be determined.It is possible that the rupture occurred due to interaction with lesion calcification or associated devices, causing damage to the outer surface of the balloon material; however, this could not be confirmed.The specifics of reported pressure/atmospheres are unknown.The difficulty removing was possibly due to the ruptured balloon material getting caught on the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9369137
• Report Number: 2024168-2019-13847
• Device Sequence Number: 19593911
• Product Code: LIT
• UDI-Device Identifier: 08717648154775
• UDI-Public: 08717648154775
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 02/25/2020

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: 01/31/2023
• Device Model Number: B1070-020
• Device Catalogue Number: B1070-020
• Device Lot Number: 90806G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/25/2020
• 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