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

Model Number	24634
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.A 5.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon burst when inflated at 4atm inside patient.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen 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 1mm proximal of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon burst.A 5.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon burst when inflated at 4atm inside patient.There were no patient complications 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: 9716440
• Report Number: 2134265-2020-01627
• Device Sequence Number: 355056
• Product Code: PNO
• UDI-Device Identifier: 08714729813699
• UDI-Public: 08714729813699
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 09/09/2021
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0024405758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1