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

Model Number 39467-150

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problems Pain (1994); Discomfort (2330); Obstruction/Occlusion (2422); Diaphoresis (2452)

Event Date 08/18/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced pain and discomfort; a burr was stuck in the lesion and a shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 1.50mm rotapro, two 7f guidezilla ii guide catheter and a rotawire drive guidewire were selected for use.During the procedure, the physician set the rotapro burr to 160k rpm speed and began ablating.Two runs were completed for 15 seconds.On the third run, the rpm speed began to drop and came down to 124 rpm speed and 102 rpm speed and then stalled in the mid lad.It was attempted to move the rotapro burr using the rotapro dynaglide mode and full rpm speed, but the rotapro burr remained stalled and stuck in the lesion.The physician advanced the rotapro burr fully and disconnected the rotapro burr from the rotapro advancer.A hemostat was connected onto the rotapro burr connection to the rotapro advancer and it was attempted to 'jump rope' counter clockwise to manually dislodge the burr, with no resolution.The rotapro burr sheath and rotawire were cut away from the rotapro advancer.A guidezilla ii guide catheter was inserted but was unable to advance.A second guidezilla ii guide catheter was attempted, however it broke before being fully inserted into the guide catheter.The 25cm catheter of the guidezilla ii separated from the hypotube component, however the device was still intact and removed successfully.It was noted that the physician thought a 7f guide catheter was being utilized however, it was a 6f guide.The physician attempted to use a 6f guide with no success due to it being a 5 f inner diameter.It was then attempted to place a non-bsc coronary guidewire next to the burr, however it could not be advanced.The patient remained stable but experienced chest discomfort and became diaphoretic.Pain medication was administered for the discomfort.Following pain medication administration, the rotapro burr was attempted to be removed by pulling with more force, with no success.Access was gained through the left groin.A7 f jl4 catheter was utilized to 'ping-ponged' the guides and de-seat the xb 4 guide catheter and seated the jl4 in the left main coronary artery (lm) for access.The guidewire was able to be advanced next to the rotapro burr and into the circumflex.A 1.5x12mm balloon was advanced to the lad and a 4.0 balloon was advanced in the circumflex for perforation precautions.The 1.5x12mm balloon was inflated next to the rotapro burr and successfully dislodged the burr.The rotapro burr and rotawire were removed with no difficulties as one unit.The xb4 guide was removed and a normal pci took place.The patient remained stable and successful balloon and stent placements were obtained.The patient was admitted per protocol to the icu and is to be observed.No further complications were reported and the patient was discharged the next day.The devices were disposed by the healthcare facility.

• 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 SCIMED, INC; 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: 17739498
• MDR Text Key: 323322048
• Report Number: 2124215-2023-47278
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0030934906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 93 YR
• Patient Sex: Male