MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number	24628
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon leak occurred.A 5.00mmx2.00cmx50cm peripheral cutting balloon was selected for use in the left arm arteriovenous fistula.During the procedure, the balloon would not hold pressure upon inflation and a small leak/hole in the balloon was noted upon removal from the patient.The procedure was completed with another device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product 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 encore inflation unit using glycerol/water.Positive pressure was applied, and a balloon leak was noted 7mm distal from the proximal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no issues with the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon leak occurred.A 5.00mmx2.00cmx50cm peripheral cutting balloon was selected for use in the left arm arteriovenous fistula.During the procedure, the balloon would not hold pressure upon inflation and a small leak/hole in the balloon was noted upon removal from the patient.The procedure was completed with another device.No patient complications were reported.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15469496
• Report Number: 2124215-2022-36159
• Device Sequence Number: 14521446
• Product Code: PNO
• UDI-Device Identifier: 08714729813705
• UDI-Public: 08714729813705
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/11/2022

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: 10/28/2022
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0026260258
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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