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

Model Number 39467-125

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524); Material Integrity Problem (2978); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported that the rotapro burr and rotawire guidewire became stuck in the lesion, the driveshaft broke requiring additional intervention.The target lesion was located in the severely calcified and tortuous mid right coronary artery (rca).A 1.25mm rotapro and rotawire were selected for use.During the procedure, difficulty was noted when advancing burr in guide catheter (non bsc).Burring of the rca in the old stent was initiated, however a stall was noted and the rotapro burr and rotawire became stuck in the rca mid part lesion.During ablation of the lesion after approximately 2 min of total run time, it was noted that the device broke at the connection between the driveshaft and the proximal end of the burr as there was no movement of burr when the advancer was moved.Multiple attempts and methods were done to remove the entrapped rotapro burr.Secondary access was also attempted, and snares were used, but resolution was not successful.The rotapro was cut off with scissors distal to handshake connection.A non bsc guide extension was placed over the broken rotapro driveshaft and catheter.A buddy wire was inserted beyond the trapped rotapro burr.A 2.00mm balloon was placed over the buddy wire, inflated at the ostium, then deflated and immediately advanced to the guide extension.The guide extension was positioned proximal to the broken burr.Another balloon, inflated at low (6atm) pressure, was placed over the buddy wire to pull the burr into the guide extension.The combined use of the buddy wire, balloons, and guide extension allowed for the safe removal of the broken burr, removing all devices in one unit.The procedure was completed and the entirety of the procedure lasted almost four hours.The patient was fully recovered.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19153731
• MDR Text Key: 340726400
• Report Number: 2124215-2024-22300
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0033412123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2024
• 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
• Treatment: 7F GUIDE EXTENSION CATHETER -MEDTRONIC
• Patient Outcome(s): Required Intervention