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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device became stuck in the lesion, and the shaft separated.A 2.0mm rotapro was selected for use in a percutaneous coronary intervention (pci) procedure of the mid left anterior descending (lad) artery.The anatomy was moderately tortuous with severe calcification and 75% stenosis.There was difficulty during removal, and the device became stuck in the lesion.The shaft separated and was removed using the microcatheter.The procedure was successfully completed with a non-bsc device.There were no patient complications reported.
Event or Problem Description
It was reported that the device became stuck in the lesion, and the shaft separated.A 2.0mm rotapro was selected for use in a percutaneous coronary intervention (pci) procedure of the mid left anterior descending (lad) artery.The anatomy was moderately tortuous with severe calcification and 75% stenosis.There was difficulty during removal, and the device became stuck in the lesion.The shaft separated and was removed using the microcatheter.The procedure was successfully completed with a non-bsc device.There were no patient complications reported.It was further reported that the shaft of the catheter was intentionally cut and another catheter was inserted to remove the rotapro from the body.Rotablation was performed with a 1.75mm device.

• 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: 10514370
• Report Number: 2134265-2020-12544
• Device Sequence Number: 3539287
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 04/24/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025469021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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