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	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and non-calcified vessel forearm.A 6.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during inflation at 40 atmospheres, the balloon ruptured.The device was removed without any problem.The procedure was completed with the original device.There were no patient complications nor injuries reported, and the patient condition was good post-procedure.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.D2b: pro code (product code): dqy.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.D2b: pro code (product code): dqy.Corrections: d4: lot number, expiration date, and h4: device manufacture date device evaluated by mfr.: athletis 6.0mm x 40mm x 75cm, 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 20mm proximal of the tip.As per athletis specification the rated burst pressure for this device is 40 atmospheres.There was no damage observed to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at approximately 280mm proximal of the proximal balloon sleeve.This type of damage is consistent with excessive force being applied to the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and non-calcified vessel forearm.A 6.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during inflation at 40 atmospheres, the balloon ruptured.The device was removed without any problem.The procedure was completed with the original device.There were no patient complications nor injuries reported, and the patient condition was good post-procedure.

• 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: 17568531
• Report Number: 2124215-2023-39869
• Device Sequence Number: 6966962
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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: 01/09/2026
• Device Model Number: 39347-060470
• Device Catalogue Number: 39347-060470
• Device Lot Number: 0030820421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - KYOUSHA35; GUIDEWIRE - KYOUSHA35
• Patient Sex: Male