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

Model Number	39347-060870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in radial arteriovenous fistula.A 6.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during inflation, the balloon burst.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
D2b: pro code (product code): dqy.
Additional Manufacturer Narrative
D2b: pro code (product code): dqy.Device evaluated by mfr: an athletis device was received for analysis was received for analysis.A visual examination identified that the balloon was not subjected to positive pressure as the balloon was received with the balloon protector covering the balloon.The investigator removed the balloon protector to confirm that the balloon was not subjected to positive pressure.The rated burst pressure for this device is 40 atmospheres.The returned device was attached to an inflation unit.Positive pressure was applied, and no leaks or issues was noted with the balloon.A visual and tactile examination identified multiple shaft kinks along the length of the shaft.A visual and tactile examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in radial arteriovenous fistula.A 6.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during inflation, the balloon burst.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.

• 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: 17282807
• Report Number: 2124215-2023-34792
• Device Sequence Number: 14322699
• Product Code: LIT
• UDI-Device Identifier: 08714729973836
• UDI-Public: 08714729973836
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/07/2023

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: 01/09/2026
• Device Model Number: 39347-060870
• Device Catalogue Number: 39347-060870
• Device Lot Number: 0030820423
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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 Age: 53 YR
• Patient Sex: Male