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

Model Number	39347-070470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (additional product code): dqy.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified radial arteriovenous fistula.A 7.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was tightly folded, which indicates that the device was not 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 34 atmospheres for 30 seconds using deionizes water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 34 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure of 34 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found a kink to the shaft of the device located approximately 180mm proximal of the proximal balloon bond.This type of damage is consistent with excessive force being applied to the device.D2b - pro code (additional product code): dqy.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified radial arteriovenous fistula.A 7.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient condition was stable.

• 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: 18250185
• Report Number: 2124215-2023-63504
• Device Sequence Number: 6644551
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: 08714729973911
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 03/20/2026
• Device Model Number: 39347-070470
• Device Catalogue Number: 39347-070470
• Device Lot Number: 0031272251
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: 60 YR
• Patient Sex: Female