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

Model Number	24642
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.
Event or Problem Description
It was reported that the balloon fell apart.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, it was noted the balloon fell apart upon opening.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Device evaluated by mfr: the device was returned for analysis.A visual and tactile examination identified a full balloon detach from the shaft.The break point was observed at the distal end of the shaft and there was also evidence that the bond was present at the proximal bond area of the shaft.Traces of the inner shaft were identified on the detached balloon.There was no evidence of bond failures on the device.An examination of the detached balloon identified no issues.All blades were present and fully bonded to the balloon surface.The blades of the device were visually and microscopically examined, and no issues were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon fell apart.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, it was noted the balloon fell apart upon opening.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 9897818
• Report Number: 2134265-2020-03973
• Device Sequence Number: 2818564
• Product Code: PNO
• UDI-Device Identifier: 08714729819769
• UDI-Public: 08714729819769
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: Other
• Device Expiration Date: 06/17/2021
• Device Model Number: 24642
• Device Catalogue Number: 24642
• Device Lot Number: 0022262675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1