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

Model Number B1070-020

Device Problems Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 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.

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
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9369137
• MDR Text Key: 167980657
• Report Number: 2024168-2019-13847
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154775
• UDI-Public: 08717648154775
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention