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

Model Number	24630
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon detachment occurred.A 7.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon detached upon performing a dialysis access angioplasty.The procedure was changed to an open "cut-down" for balloon isolation and surgically removed it from the vessel.No further complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was returned in two pieces; the balloon was separated from the device shaft.Only a segment of the proximal balloon sleeve remained attached to the device, most of the balloon and the whole tip section of the device were removed.The balloon was returned in 2 sections- a full circumferential tear was present on the balloon material of both sections.Section 1 of the balloon material was attached to the shaft of the device.Section 2 of the balloon material includes the remainder of the balloon with the blades and distal cone of the balloon attached.No tip or marker bands were present on either section of the balloon material.No issues noted with the blades of this device.All blades bonded securely to the balloon surface.No tip was returned with the device.No marker bands were returned with the device.A visual and tactile examination identified blood within the shaft of the device.
Event or Problem Description
It was reported that a balloon detachment occurred.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon detached upon performing a dialysis access angioplasty.The procedure was changed to an open "cut-down" for balloon isolation and surgically removed it from the vessel.No further complications were reported and patient was stable post procedure.

• 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: 10087993
• Report Number: 2134265-2020-06948
• Device Sequence Number: 2561227
• Product Code: PNO
• UDI-Device Identifier: 08714729813774
• UDI-Public: 08714729813774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 01/02/2021
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0023133136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention