MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotapro became stuck on the rotawire and was difficult to remove.A 2.00mm rotapro and rotawire were selected for use in a percutaneous coronary intervention (pci) in the mid left anterior descending (lad) artery.The 75% stenosed target lesion was severely calcified and located in moderately tortuous anatomy.During the procedure, after performing one ablation run at a rotation speed of 180,000 rpms, there was difficulty removing the device.The rotapro was removed together with the guidewire.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10924360
• Report Number: 2134265-2020-16404
• Device Sequence Number: 4258690
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 07/24/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025764417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1