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

Model Number	24642
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.Vascular access was obtained via vein graft angioplasty approach.A stenosed target lesion was located at basilic vein.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, upon inflation, the physician stated that the balloon did not inflate.It was noted that a balloon rupture occurred the device was replaced with another of the same device.There were no patient complications and the patient was stable upon completion of the case.
Additional Manufacturer Narrative
Device evaluated by mfr: examination of the returned device revealed the balloon was not folded, indicating the balloon was subjected to positive pressure the balloon was inflated to its rate of burst pressure at 12 atmospheres without issue.This was attempted three times and no leaks or drops in pressure were noted.No issues were found during the inspection of the remainder of the device.
Event or Problem Description
It was reported that a balloon rupture occurred.Vascular access was obtained via vein graft angioplasty approach.A stenosed target lesion was located at basillic vein.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, upon inflation, the physician stated that the balloon did not inflate.It was noted that a balloon rupture occurred the device was replaced with another of the same device.There were no patient complications and the patient was stable upon completion of the case.

• 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: 8271333
• Report Number: 2134265-2019-00293
• Device Sequence Number: 16470468
• Product Code: PNO
• UDI-Device Identifier: 08714729819769
• UDI-Public: 08714729819769
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 03/04/2019

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: 06/17/2021
• Device Model Number: 24642
• Device Catalogue Number: 24642
• Device Lot Number: 0022262850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1