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

Model Number	24630
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon could not be deflated and was punctured to remove the device.The target lesion was located in the femoral and popliteal veins.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be deflated and had to be punctured to remove the device from the patient body.No patient complications were reported.
Additional Manufacturer Narrative
E3 corrected to other healthcare professional.Device evaluated by manufacturer: the device was returned for analysis.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 and microscopically examined, and a partial circumferential tear was noted 3mm distal from the proximal markerband.A visual examination of the returned device identified no issues with the blades of the device.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 multiple shaft kinks along the length of the device.No kinks or damage to the shaft of the returned device.
Event or Problem Description
It was reported that the balloon could not be deflated and was punctured to remove the device.The target lesion was located in the femoral and popliteal veins.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be deflated and had to be punctured to remove the device from the patient body.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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16620076
• Report Number: 2124215-2023-11842
• Device Sequence Number: 5923896
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 09/30/2023
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0028115456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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 Age: 46 YR
• Patient Sex: Male