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

Model Number	39347-060450
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code (product code): lit-dqy.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for vascular access intervention therapy.The 95% stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified cephalic vein.A 6.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilatation.However, during the second inflation at 25 atmospheres, the balloon ruptured.Additionally, a crack in the inflation lumen of the hub was observed from which pressure was thought to have leaked.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
D2b - pro code (product code): lit-dqy.Device evaluated by mfr.: an athletis device was received for analysis.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure and there was no evidence that the balloon was inflated.A visual and tactile examination identified no kinks or damage to the shaft.The hub of the device was found to have a crack located in the inflation port.The balloon was unable to be inflated due to the cracked hub.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for vascular access intervention therapy.The 95% stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified cephalic vein.A 6.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilatation.However, during the second inflation at 25 atmospheres, the balloon ruptured.Additionally, a crack in the inflation lumen of the hub was observed from which pressure was thought to have leaked.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16303243
• Report Number: 2124215-2023-02717
• Device Sequence Number: 12308342
• Product Code: LIT
• UDI-Device Identifier: 08714729973782
• UDI-Public: 08714729973782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 08/22/2025
• Device Model Number: 39347-060450
• Device Catalogue Number: 39347-060450
• Device Lot Number: 0030005503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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