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

Model Number	B1050-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
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 other complaints.The armada 35 instructions for use (ifu), states: inflation in excess of the rated burst pressure may cause the balloon to rupture.Based on the information provided, the reported balloon rupture was likely user related.It is likely that the balloon rupture was the result of inflating the balloon above the rated burst pressure.Additionally, it is likely that during removal, the ruptured balloon material caught on the introducer sheath and separated.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 performed to treat a re-stenosed lesion in the moderately calcified, mildly tortuous, 70% stenosed radial artery with a fistula.A 5x60mm armada 35 percutaneous transluminal angioplasty (pta) balloon was inflated above rated burst pressure to 20 atmospheres and ruptured.After deflation, the balloon separated from the catheter, and the catheter faced resistance during removal with the anatomy.The separated portion was retrieved through a puncture in the brachial artery with an unspecified sheath.No portion of the device remains in the anatomy.There were no adverse patient sequelae, but there was a 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: 9910689
• Report Number: 2024168-2020-03200
• Device Sequence Number: 17002988
• Product Code: LIT
• UDI-Device Identifier: 08717648154614
• UDI-Public: 08717648154614
• 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
• Report Date (Section B): 04/01/2020

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: 12/31/2022
• Device Model Number: B1050-060
• Device Catalogue Number: B1050-060
• Device Lot Number: 90722G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/01/2020
• 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