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

Model Number	24634
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon failed to deflate and damaged the fistula.The target lesion was located in the fistula in the arm.An 8.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During removal, the balloon failed to deflate.There were multiple failed attempts to deflate the balloon by pulling negative pressure.The balloon appeared to have been deflated when reached the tip of the sheath for removal, however it was not deflated.The balloon and sheath were removed as a system which resulted in damage of the fistula and the skin at the insertion point.The fistula was then closed to the skin.The procedure was completed with this device.No further 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
• MDR Report Key: 10344994
• Report Number: 2134265-2020-10163
• Device Sequence Number: 2309995
• Product Code: PNO
• UDI-Device Identifier: 08714729813781
• UDI-Public: 08714729813781
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/30/2020

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: 07/23/2020
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0022416933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/30/2020
• 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