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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter city: (b)(6).
Event or Problem Description
It is reported that a rotapro and rotawire entrapment occurred.A 1.75mm rotapro and a 300cm rotawire were selected for use in a percutaneous coronary intervention (pci) procedure.The 90% stenosed target lesion was moderately tortuous and severely calcified right coronary artery (rca).The device was prepared outside the body and platformed at 180,000rpm, then advanced over the wire.During procedure, the burr became stuck on the wire inside the patient.The devices were removed together as one unit, and severe resistance was felt during removal.After it was removed, the physician noticed the rotawire was kinked.The procedure was completed successfully with this device and there were no patient complications reported.
Event or Problem Description
It is reported that a rotapro and rotawire entrapment occurred.A 1.75mm rotapro and a 300cm rotawire were selected for use in a percutaneous coronary intervention (pci) procedure.The 90% stenosed target lesion was moderately tortuous and severely calcified right coronary artery (rca).The device was prepared outside the body and platformed at 180,000rpm, then advanced over the wire.During procedure, the burr became stuck on the wire inside the patient.The devices were removed together as one unit, and severe resistance was felt during removal.After it was removed, the physician noticed the rotawire was kinked.The procedure was completed successfully with this device and there were no patient complications reported.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter city: (b)(6).Device evaluated by mfr: the returned product consisted of the rotapro atherectomy system and the burr catheter was attached to the advancer unit.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device presented no damage or irregularities.The wire used in the procedure was returned, so functional testing was completed with the returned rotawire.The wire was able to be inserted into the burr and advanced through the advancer with no resistance or issues.

• 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: 11924617
• Report Number: 2134265-2021-07136
• Device Sequence Number: 948633
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 01/27/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026707725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/15/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1