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	Vascular Dissection (3160)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon burst and lacerated the vein.The 80% stenosed target lesion was located in the moderately tortuous radial cephalic fistula.A 7.00 mm /2.0 cm /90 cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon burst at 8atm upon third inflation.The balloon needs to be taken out from the patient's body but it was not fully collapsed.Subsequently, the balloon lacerated the cephalic vein and the non-bsc sheath.The patient was then sutured and the procedure was completed with a different device.No further complications were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The tip section of the device was visually and microscopically examined, and no issues were noted that could have potentially contributed to the complaint incident.A visual and microscopic examination identified no issues with the blades.All blades were present and fully bonded to the balloon material.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.A microscopic examination identified a balloon pinhole located approximately 3mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres.A visual and microscopic examination found no issues with the markerbands of the device.A visual and tactile examination identified no issues with the shaft of the device that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon burst and lacerated the vein.The 80% stenosed target lesion was located in the moderately tortuous radial cephalic fistula.A 7.00 mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon burst at 8atm upon third inflation.The balloon needs to be taken out from the patient's body but it was not fully collapsed.Subsequently, the balloon lacerated the cephalic vein and the non-bsc sheath.The patient was then sutured and the procedure was copleted with a different device.No further complications were reported and the patient is fine.

• 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: 9084704
• Report Number: 2134265-2019-11356
• Device Sequence Number: 2700817
• Product Code: PNO
• UDI-Device Identifier: 08714729813774
• UDI-Public: 08714729813774
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/22/2019

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: 02/04/2021
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0023297042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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