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

Model Number	39347-051050
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code (product code): dqy.Device eval by manufacturer: a visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test identified a pinhole in the balloon material approximately 1mm proximal of the tip.A visual examination of the balloon material, tip, and marker bands identified no issues which could potentially have contributed to this complaint.No damage or kinks were noted along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 07nov2022.An athletis 5.0mm x 100mm x 50cm was selected for use in the dialysis shunt percutaneous transluminal angioplasty (pta) procedure.The patient anatomy was reported to be severely calcified.During the procedure, the athletis was advanced to the target lesion, and upon initial dilation, contrast was observed to be leaking from the device.There was no visible damage to the balloon.The device was removed and replaced to complete the procedure.There were no reported adverse consequences to the patient.The athletis was returned for investigation.Device analysis revealed a pinhole rupture on the balloon.

• 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: 15890711
• Report Number: 2124215-2022-46118
• Device Sequence Number: 6699237
• Product Code: LIT
• UDI-Device Identifier: 08714729973720
• UDI-Public: 08714729973720
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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: 02/13/2025
• Device Model Number: 39347-051050
• Device Catalogue Number: 39347-051050
• Device Lot Number: 0028863608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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