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 Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the non calcified right upper arm cephalic vein.A 7.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at 2atm.The device was removed and the procedure was completed with a different device.No patient complications were reported.The patient status was good and was discharged.
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 balloon was subjected to positive pressure.A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.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 detected in the mid-section of the balloon material.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the blades.All blades were intact and fully bonded to the balloon surface.No damage or any issues were noted with the blades that could have contributed to the complaint incident.No issues were noted with the tip section of the device.A visual and microscopic examination of the markerbands was completed.There was no burrs or uneven edges observed on the markerbands.No damage or any issues were noted with the markerbands that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the non calcified right upper arm cephalic vein.A 7.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at 2atm.The device was removed and the procedure was completed with a different device.No patient complications were reported.The patient status was good and was discharged.

• 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: 8893566
• Report Number: 2134265-2019-09709
• Device Sequence Number: 10842496
• Product Code: PNO
• UDI-Device Identifier: 08714729813767
• UDI-Public: 08714729813767
• 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): 09/17/2019

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: 08/25/2019
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0021055697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR