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

Model Number	39347-060470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified cephalic vein.A 6.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was selected for the vascular access interventional therapy case.However, during the first inflation at 20 atmospheres for 10 seconds duration time, the balloon ruptured.The device was able to be removed using the normal method without any issues.Another athletis balloon was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Product code- lit, dqy.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified cephalic vein.A 6.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was selected for the vascular access interventional therapy case.However, during the first inflation at 20 atmospheres for 10 seconds duration time, the balloon ruptured.The device was able to be removed using the normal method without any issues.Another athletis balloon was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
D2b: product code- lit, dqy.E1: initial reporter phone corrected and initial reporter email removed.Device evaluated by manufacturer: an athletis device batch #29625407, 40 atm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual examination identified a longitudinal tear in the distal region of the balloon approximately 6mm in length.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.This concludes the product analysis.

• 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: 15729833
• Report Number: 2124215-2022-44503
• Device Sequence Number: 2995588
• Product Code: LIT
• UDI-Device Identifier: 08714729973799
• UDI-Public: 08714729973799
• 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): 11/28/2022

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: 06/20/2025
• Device Model Number: 39347-060470
• Device Catalogue Number: 39347-060470
• Device Lot Number: 0029625407
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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