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

Model Number	24634
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	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blade came loose.A 6.00mmx2.0cmx135cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade came loose when they were pulling it out of the sheath at the end of the case.No complications reported and no patient was harmed.
Event or Problem Description
It was reported that the blade came loose.A 6.00mmx2.0cmx135cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade came loose when they were pulling it out of the sheath at the end of the case.No complications reported and no patient was harmed.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination of the returned device identified that approximately 12mm of a blade were noted to have lifted on one of the blades.All other blades were present and fully bonded to the balloon surface.The customers introducer sheath was not returned with the device.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon of the device was visually examined, and no issues were noted that may have potentially contributed to the complaint incident.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.No other issues were identified during the product analysis.

• 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: 15475374
• Report Number: 2124215-2022-36656
• Device Sequence Number: 4323490
• Product Code: PNO
• UDI-Device Identifier: 08714729813729
• UDI-Public: 08714729813729
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 10/06/2023
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0028149987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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