MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	39347-080470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b pro code (product code): dqy.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the mildly calcified fistula.Two 8.0mm x 40mm x 75cm athletis balloon catheters were advanced for dilation.However, the first balloon ruptured when it was inflated at 24 atmospheres (atm), and the second balloon also burst when inflated at 26atm.The physician believed that there may have been a balloon perforation after inflating with these balloons as there was contrast leaking after angiography.Both devices were removed and there were no fragments left inside the patient.The procedure was completed with a 10mm non-boston scientific balloon catheter.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the mildly calcified fistula.Two 8.0mm x 40mm x 75cm athletis balloon catheters were advanced for dilation.However, the first balloon ruptured when it was inflated at 24 atmospheres (atm), and the second balloon also burst when inflated at 26atm.The physician believed that there may have been a balloon perforation after inflating with these balloons as there was contrast leaking after angiography.Both devices were removed and there were no fragments left inside the patient.The procedure was completed with a 10mm non-boston scientific balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
D2b pro code (product code): dqy.Device evaluated by mfr: athletis 8.0mm x 40mm x 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon pinhole was identified located approximately 15mm distal of the proximal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17031852
• Report Number: 2124215-2023-24014
• Device Sequence Number: 12489886
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: 08714729974055
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 08/16/2025
• Device Model Number: 39347-080470
• Device Catalogue Number: 39347-080470
• Device Lot Number: 0029967927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown