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	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code (product code): lit, dqy.
Event or Problem Description
It was reported that a balloon burst occurred.The 70% stenosed target lesion was located in the mildly calcified and severely tortuous arteriovenous fistula (avf).A 6.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was selected for use in a percutaneous transluminal angioplasty (pta) procedure.During inflation, the balloon burst inside the patient's body.A mustang balloon was used to complete the procedure.There were no patient complications and the patient status was stable.
Additional Manufacturer Narrative
D2b: pro code (product code): lit, dqy.Device evaluated by mfr: the athletis 6.0mm x 80mm x 75cm, batch # 29225991, 40atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 40 atmospheres for 30 seconds using digital timer, without issue.A vacuum was then applied.The inflation device was verified at 40 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 40 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely kinked at approximately 330mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that a balloon burst occurred.The 70% stenosed target lesion was located in the mildly calcified and severely tortuous arteriovenous fistula (avf).A 6.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was selected for use in a percutaneous transluminal angioplasty (pta) procedure.During inflation, the balloon burst inside the patient's body.A mustang balloon was used to complete the procedure.There were no patient complications and the patient status was stable.

• 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: 15253946
• Report Number: 2134265-2022-08580
• Device Sequence Number: 5808453
• 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): 11/02/2022

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: 04/13/2025
• Device Model Number: 39347-060870
• Device Catalogue Number: 39347-060870
• Device Lot Number: 0029225991
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female