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

Model Number	10273
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 20 x 2.50 rebel stent was selected for use.However, upon removing the device from the hoop, the stent was stripped off and was left on the stylet.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 20 x 2.50 rebel stent was selected for use.However, upon removing the device from the hoop, the stent was stripped off and was left on the stylet.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a rebel bms stented catheter.The balloon was loosely folded.The stent was returned separated from the balloon.There is dried contrast/saline in the lumen and a small amount of blood noticed between the balloon folds.Although it was reported that the device was not used, the presence of blood and contrast media in the lumen is indicative of handling beyond simply unpackaging the device, as was reported.The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.The separated stent was severely stretched/damaged.There are numerous hypotube kinks.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9391970
• Report Number: 2134265-2019-14642
• Device Sequence Number: 14098135
• Product Code: MAF
• UDI-Device Identifier: 08714729843832
• UDI-Public: 08714729843832
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 04/02/2022
• Device Model Number: 10273
• Device Catalogue Number: 10273
• Device Lot Number: 0023584515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1