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

Model Number	24630
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
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 a stent graft of the right superficial femoral artery.A 6.00 mm / 2.0 cm / 90 cm otw peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon inflation.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for evaluation.Visual inspection of the balloon and markerbands observed that the balloon was not folded indicating the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The device was then attached to an encore inflation unit and positive pressure was applied.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath to help soften the media before further inflation attempts were made.The device was then removed from the bath and the balloon was again attached to an inflation device and positive pressure was applied; however, the balloon still could not be inflated.A microscopic examination observed a balloon pinhole located approximately 6mm distal of the proximal balloon bond.An examination of the balloon material and markerbands noted no issues.Visual and tactile examination of the shaft noted a kink on the shaft of the device at the distal edge of the strain relief.Visual and microscopic examination of the tip and blades observed no damage.All blades were present and fully bonded to the balloon surface.No other issues were identified.
Event or Problem Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in a stent graft of the right superficial femoral artery.A 6.00mm/2.0cm/90cm otw peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon inflation.The procedure was completed with another of the same device.No 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: 8982410
• Report Number: 2134265-2019-10879
• Device Sequence Number: 19652067
• Product Code: PNO
• UDI-Device Identifier: 08714729813743
• UDI-Public: 08714729813743
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 03/29/2020
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0021932538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1