MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24658
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal portion of the catheter separated.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, it was noted that when the outer/protective sheath was removed, the distal portion of the catheter became separated.The device was never in the patient's body.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the distal portion of the catheter separated.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, it was noted that when the outer/protective sheath was removed, the distal portion of the catheter became separated.The device was never in the patient's body.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the patient was fine post procedure.
Event or Problem Description
It was reported that the distal portion of the catheter separated.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, it was noted that when the outer/protective sheath was removed, the distal portion of the catheter became separated.The device was never in the patient's body.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was returned with the balloon protector partially removed the device and the proximal balloon folds were found to be unfolded.The investigator was unable to apply a vacuum to the device as per preparation instructions due to a shaft break.For investigation purposes the investigator removed the balloon protector with a little resistance experienced as negative pressure could not be applied to the device.The balloon protector's inner diameter was verified at 0.0435 inch using a calibrated pin gauge.A visual examination identified that the balloon was not subjected to positive pressure.The balloon material and blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were fully bonded to the balloon material.A visual and tactile examination found the shaft polymer extrusion to be completely detached at the guidewire port.This type of damage is consistent with excessive tensile force being applied to the device.A visual and tactile examination found no kinks or damage to the hypotube of the device.A visual and microscopic investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10282725
• Report Number: 2134265-2020-09417
• Device Sequence Number: 11407508
• Product Code: PNO
• UDI-Device Identifier: 08714729819714
• UDI-Public: 08714729819714
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070951
• 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,Followup
• Report Date (Section B): 08/17/2020

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: 08/14/2022
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0024273265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 08/12/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/23/2020; 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1