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

Model Number	3243
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr stuck on the guidewire.A 2.0mm rotapro and a rotawire were selected for a mid-left anterior descending (lad) artery atherectomy procedure with percutaneous coronary intervention (pci).During withdrawal, the burr got stuck on the wire.The rotapro and rotawire were removed together from the patient.The procedure was completed and there were no patient complications.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).Device returned and analyzed by manufacturer.The returned complaint device consisted of a rotapro device.The burr catheter was received attached to the advancer unit.The rotawire used during the procedure was not returned.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically examined.There were numerous sheath kinks.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil is stretched.The rotawire that was used during the procedure was not returned; functional testing was performed using a test.009 rotawire.The test rotawire was inserted through the burr and advanced through the entire length of the device with no resistance.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr stuck on the guidewire.A 2.0mm rotapro and a rotawire were selected for a mid-left anterior descending (lad) artery atherectomy procedure with percutaneous coronary intervention (pci).During withdrawal, the burr got stuck on the wire.The rotapro and rotawire were removed together from the patient.The procedure was completed and there were no patient complications.

• 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: 9466035
• Report Number: 2134265-2019-15690
• Device Sequence Number: 4115118
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056/S166
• 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): 02/05/2020

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: 08/27/2021
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0024340939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1