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

Model Number	24630
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	09/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred and was removed through a snare.The 70-90% stenosed target lesion was located in the mild to moderately tortuous and a very mild, intimal fibrosis calcified fistula.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During withdrawal, resistance was felt.When the device reached the end of the sheath, it was noted that the balloon was detached from the catheter.The catheter came out through the sheath over the wire and was removed altogether leaving the balloon within the fistula.The physician was able to access a new location site and removed the balloon through snaring.No further complications were reported and patient was well post procedure.

• 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
• MDR Report Key: 12569573
• Report Number: 2134265-2021-12250
• Device Sequence Number: 872129
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0026088693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention