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

Model Number 3243

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled/rescheduled post-sedation.A 1.25mm rotapro was selected for use in a percutaneous coronary intervention (pci) procedure of the left anterior descending (lad) artery.The patient was being treated for calcified coronary artery disease.The vessel was initially wired with a non-bsc workhorse wire, but it was then exchanged for a rotawire.While attempting to load the rotapro burr onto the rotawire, resistance was felt near the advancer.The user was moving the advancer knob, but the distal gripper was removed.Since the rotawire would not pass through the advancer, the rotapro was removed.Upon removal, the device broke at the drive shaft connector.The drive shaft connector piece broke off inside the catheter body.The procedure was not completed because another 1.25mm burr was not available.The rotawire was not kinked or damaged.No patient complications were reported, and the patient was stable post-procedure.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10488932
• MDR Text Key: 205877723
• Report Number: 2134265-2020-12236
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0024515009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1