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

Model Number	24634
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and fibrous non calcified femoral vein graft.A 6.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During procedure, the balloon was inflated at 1atm every 5 seconds.Balloon was continually inflated even though the pressure would decrease quickly so blood return was not noticed as soon as it probably could have been.The balloon was up for at least 60 seconds.The physician tried to keep the balloon at nominal pressure; however, it quickly burst before reaching nominal pressure of 6atm and the blood return kept getting pushed back due to rotation of the inflation device.The doctor was displeased that she could not bring the balloon to 10atm which is the rated burst as this was a tough lesion.The balloon was pinned pulled off the wire from the patient's body with no problem and the procedure was completed with a different device.No patient complications were reported, nothing broke off and was left in the patient's body.

• 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: 11178825
• Report Number: 2134265-2020-18867
• Device Sequence Number: 2231624
• Product Code: PNO
• UDI-Device Identifier: 08714729813729
• UDI-Public: 08714729813729
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 07/03/2021
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0024057292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1