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

Model Number	39347-050450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.A 5.0mm x 40mm x 50cm athletis balloon was selected for use in a shunt percutaneous transluminal angioplasty procedure.The dialysis shunt was severely calcified.On the first inflation, the balloon ruptured at 10atm.The device was removed without issue.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in good condition after the procedure.The physician noted that not only was the dilated site calcified but also the blood vessels were highly calcified as a whole.The physician suspected that inflation was not a direct factor, but the device may have torn during delivery.
Additional Manufacturer Narrative
Pro code - additional product code: dqy.
Additional Manufacturer Narrative
D2b: pro code - additional product code: dqy.Device eval by manufacturer: the athletis device was received for analysis.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.The returned device was attached to an inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 3mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic 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.
Event or Problem Description
It was reported that the balloon ruptured.A 5.0mm x 40mm x 50cm athletis balloon was selected for use in a shunt percutaneous transluminal angioplasty procedure.The dialysis shunt was severely calcified.On the first inflation, the balloon ruptured at 10atm.The device was removed without issue.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in good condition after the procedure.The physician noted that not only was the dilated site calcified but also the blood vessels were highly calcified as a whole.The physician suspected that inflation was not a direct factor, but the device may have torn during delivery.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14553101
• Report Number: 2134265-2022-06185
• Device Sequence Number: 12119177
• Product Code: LIT
• UDI-Device Identifier: 08714729973669
• UDI-Public: 08714729973669
• 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): 07/08/2022

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: 05/23/2022
• Device Model Number: 39347-050450
• Device Catalogue Number: 39347-050450
• Device Lot Number: 0026413942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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