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	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older (mid-60's).
Event or Problem Description
It was reported that the balloon rupture occurred.Two 8.00mmx2.0cmx90cm peripheral cutting balloons were selected for use on the dialysis graft.During procedure, it was noted that the balloon ruptured at 3 atmospheres.The device was removed and another balloon was inserted into the patient.However, the second balloon also ruptured and the blades did not collapse fully and became stuck just outside the sheath when attempting to remove.A snare was used to grab the stuck balloon and aid in removal.The device was removed successfully and the procedure was prolonged due to this event.No complications were reported and no harm occurred to the patient.
Event or Problem Description
It was reported that the balloon rupture occurred.Two 8.00mmx2.0cmx90cm peripheral cutting balloons were selected for use on the dialysis graft.During procedure, it was noted that the balloon ruptured at 3 atmospheres.The device was removed and another balloon was inserted into the patient.However, the second balloon also ruptured and the blades did not collapse fully and became stuck just outside the sheath when attempting to remove.A snare was used to grab the stuck balloon and aid in removal.The device was removed successfully and the procedure was prolonged due to this event.No complications were reported and no harm occurred to the patient.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older (mid-60's).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.A microscopic examination identified a balloon longitudinal tear beginning approximately 5mm proximal of the distal markerband and extending approximately 7mm distal of the distal markerband.An examination of the balloon material and markerbands 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.

• 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: 10969459
• Report Number: 2134265-2020-17141
• Device Sequence Number: 14506685
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/19/2021

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: 08/28/2022
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0025930836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - 200CM V-18 CONTROLWIRE; GUIDEWIRE - 200CM V-18 CONTROLWIRE; INTRODUCER SHEATH - 10CM CORDIS 7FR; INTRODUCER SHEATH - 10CM CORDIS 7FR; GUIDEWIRE - 200CM V-18 CONTROLWIRE; INTRODUCER SHEATH - 10CM CORDIS 7FR