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

Model Number	24628
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2022 as the event date was not reported.
Event or Problem Description
It was reported that the blade was lifted.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the cutting wire broke free.No patient complications were reported.
Event or Problem Description
It was reported that the blade was lifted.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the cutting wire broke free.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used 03/01/2022 as the event date was not reported.Device evaluated by mfr: the device was returned for evaluation.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.A visual examination of the returned device identified that a 10mm section of blade was noted to have lifted.The blade pad and all other blades were present and fully bonded to the balloon surface.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 a shaft kink 35mm distal from the distal end of the strain relief.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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14190632
• Report Number: 2134265-2022-04604
• Device Sequence Number: 4378914
• Product Code: PNO
• UDI-Device Identifier: 08714729813705
• UDI-Public: 08714729813705
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 10/28/2022
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0026260258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown