MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY

Model Number	10274
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.During preparation of a 24x3.50mm rebel stent, it was noted that the stent was damaged.No patient complications were reported as the device did not enter the patient's body.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 07:10 am ct.The report number is being corrected from: 2134265-2018-64394 to: 2134265-2018-63263.
Event or Problem Description
It was reported that stent damage occurred.During preparation of a 24x3.50mm rebel stent, it was noted that the stent was damaged.No patient complications were reported as the device did not enter the patient's body.Device evaluated by mfr.: the outer shaft, inner shaft, balloon, stent and tip were microscopically examined.There are numerous shaft kinks.There is shaft damage at the exit notch which is consistent with damage seen with the use of a guidewire.The stent is damaged 10mm from the proximal markerband.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8115970
• Report Number: 2134265-2018-63263
• Device Sequence Number: 16724925
• Product Code: MAF
• UDI-Device Identifier: 08714729843931
• UDI-Public: 08714729843931
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 03/19/2021
• Device Model Number: 10274
• Device Catalogue Number: 10274
• Device Lot Number: 0021886436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1