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

Model Number	24628
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.The 80-85% stenosed target lesion area was located in the cephalic vein confluence.An 8.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the balloon was inflated to 6 atmospheres for 30 seconds, however it did not inflate upon attempting to inflate it again in another part of the stenosis.Subsequently, the balloon ruptured and there was blood mixed in the barrel when the plunger was pulled back.The balloon was removed successfully.The procedure was completed with a different device but same indeflator.There were no patient complications reported.
Event or Problem Description
It was reported that the balloon ruptured.The 80-85% stenosed target lesion area was located in the cephalic vein confluence.An 8.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the balloon was inflated to 6 atmospheres for 30 seconds, however it did not inflate upon attempting to inflate it again in another part of the stenosis.Subsequently, the balloon ruptured and there was blood mixed in the barrel when the plunger was pulled back.The balloon was removed successfully.The procedure was completed with a different device but same indeflator.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm distal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.No kinks or damage were noted along the shaft of the device.

• 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: 11791637
• Report Number: 2134265-2021-05641
• Device Sequence Number: 17123824
• Product Code: PNO
• UDI-Device Identifier: 08714729813798
• UDI-Public: 08714729813798
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 08/12/2021

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: 08/24/2022
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0025903812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INDEFLATOR-ENCORE 26; INDEFLATOR-ENCORE 26; INDEFLATOR-ENCORE 26.