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

Model Number	24630
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: a pcb 8.00mm/2.0cm/90cm was returned for analysis.A visual and microscopic examination was performed on the returned device.The device was returned with the balloon folds in a relaxed state.A 10mm blade and pad lift were noted to have lifted on one of the blades.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.A visual and microscopic examination identified no issues with the balloon material.The returned device was attached to an encore inflation unit.Positive pressure was applied, and the balloon was successfully inflated to its rate of burst pressure of 10 atmospheres with no leaks or drops in pressure noted.The pressure was held for 30 seconds.The inflation device was verified at 10 atmospheres, before and after use with a calibrated pressure gauge.The rated burst pressure for this device is 10 atmospheres.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no damage or kinks to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 05june2020.It was reported that a bent blade occurred.The 99% stenosed target lesion was located in the mildly tortuous central venous stenosis right brachiocephalic vein.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use in a dialysis access angioplasty.During withdrawal, a bent blade was noted.However, it was further reported that the damage occurred after it was removed from the patient via the sheath.The procedure was completed with the same device.No patient complications reported and patient was stable post procedure.However, device analysis revealed a lifted 10mm blade and pad lift.

• 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: 10146025
• Report Number: 2134265-2020-07836
• Device Sequence Number: 2850752
• 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
• Report Date (Section B): 06/11/2020

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: 02/20/2022
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0025243682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1