MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	24628
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blade detachment occurred.The 50% stenosed target lesion was located in the non-tortuous arteriovenous fistula.An 8.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, a 7fr non-boston scientific sheath was placed in the vessel and a 0.35 mustang balloon catheter was used first.Subsequently, angiography shows residual stenosis, so a cutting balloon was needed.The pcb device was opened and loaded onto a v-18 guidewire across the lesion and then inflated to nominal pressure.The device was then removed and found the metal cutters were coming off the balloon.All the metal cutting pieces of the balloon were accounted for and nothing was left inside the patient.The procedure was completed, and no complications were reported.
Event or Problem Description
It was reported that blade detachment occurred.The 50% stenosed target lesion was located in the non-tortuous arteriovenous fistula.An 8.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, a 7fr non-boston scientific sheath was placed in the vessel and a 0.35 mustang balloon catheter was used first.Subsequently, angiography shows residual stenosis, so a cutting balloon was needed.The pcb device was opened and loaded onto a v-18 guidewire across the lesion and then inflated to nominal pressure.The device was then removed and found the metal cutters were coming off the balloon.All the metal cutting pieces of the balloon were accounted for and nothing was left inside the patient.The procedure was completed, and no complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the pcb 8.00mm/2.0cm/50cm otw - us was received for analysis.A visual examination of the returned device identified that the balloon had been inflated.The investigator attached the device to an encore inflation unit and filled the balloon with liquid to facilitate an inspection of the blades.The balloon of the device was visually examined, and no issues were noted.A visual examination was performed on the returned device.It was noted that approximately 16mm of the proximal end of one blade had lifted distally from its pad.The remaining 4mm of the blade remained fully bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• 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: 18484123
• Report Number: 2124215-2023-75187
• Device Sequence Number: 9133861
• Product Code: PNO
• UDI-Device Identifier: 08714729813798
• UDI-Public: 08714729813798
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 05/29/2025
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0031718121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: V-18 CONTROLWIRE.; GUIDEWIRE: V-18 CONTROLWIRE.
• Patient Sex: Unknown