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

Model Number	B1060-060
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 instruction for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.In this case, it is likely that the balloon rupture was the result of inflating the balloon twice above the rated burst pressure (rbp).Based on the information provided, the reported balloon rupture, material separation and swelling appear to be due to use error.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 a fistula vein that was moderately tortuous and 80% stenosed that was treated eight months prior.An unspecified 6 french sheath and a 035 non-abbott guide wire were used with a 6x60mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The pta balloon was inflated twice to 20 atmospheres when it ruptured.The pta catheter was removed, and the procedure was complete.Three days later, the patient came back with a swollen hand.Echocardiography was performed and it was determined that this swelling was due to a portion of the armada balloon catheter that had separated in the previous procedure and was still in the treated area of the fistula vein.A small surgical incision was made in the fistula area to remove the separated portion, and the patient was fine.There were no adverse patient sequelae and no 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: 10350479
• Report Number: 2024168-2020-06358
• Device Sequence Number: 2655903
• Product Code: LIT
• UDI-Device Identifier: 08717648154706
• UDI-Public: 08717648154706
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/31/2020

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: 05/31/2023
• Device Model Number: B1060-060
• Device Catalogue Number: B1060-060
• Device Lot Number: 91218G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: Hospitalization; Required Intervention