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

Model Number	39347-100870
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: dqy.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 10.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 10 atmospheres for 20 seconds.The device was deflated and was removed.No device fragments left inside the patient.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
D2b: pro code: dqy.Device evaluated by mfr: the athletis was returned for analysis.A visual examination identified that the balloon tightly folded which indicates that the balloon was not subjected to positive pressure.The rated burst pressure for this device is 27 atmospheres as per athletis specification.The returned device was attached to an encore inflation unit.The balloon was inflated to its rated burst pressure of 27 atm with no leaks or issues noted.A visual and tactile examination identified multiple shaft kinks.A visual and tactile examination identified no damage to the tip.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 10.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 10 atmospheres for 20 seconds.The device was deflated and was removed.No device fragments left inside the patient.The procedure was completed with another of the same device.No patient complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20456656
• Report Number: 2124215-2024-63674
• Device Sequence Number: 15423912
• Product Code: LIT
• UDI-Device Identifier: 08714729974222
• UDI-Public: 08714729974222
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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 Model Number: 39347-100870
• Device Catalogue Number: 39347-100870
• Device Lot Number: 0034488883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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