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

Model Number	24630
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
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 ruptured and was difficult to remove.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.The returned device was received with the customer's 7fr introducer sheath.The customer's sheath was torn 5mm in a proximal direction from the tip of the sheath.It was unable to advance the device through a boston scientific 7fr sheath due to a balloon circumferential tear.A visual examination of the returned device confirmed that part of the balloon and all blades were not returned with the device.A complete balloon circumferential tear was identified located approximately 14mm distal of the proximal balloon sleeve.No issues were noted with the device's tip.A visual and tactile examination identified that the shaft of the device had been stretched and accordioned.This type of damage is consistent with excessive force being applied to the device.No other issues were noted with the returned device that could potentially have contributed to the complaint incident.
Event or Problem Description
It was reported that the balloon ruptured and was difficult to remove.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.

• 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: 10969454
• Report Number: 2134265-2020-17140
• Device Sequence Number: 14506684
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 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: 01/20/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention