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

Model Number 39467-125

Device Problems Break (1069); Entrapment of Device (1212); Intermittent Loss of Power (4016)

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

Event Date 06/07/2023

Event Type  Injury  

Event Description

It was reported that the burr became stuck in the lesion, drive shaft and rotawire detached.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left main trunk (lmt) and left circumflex artery (lcx).A 1.25mm rotapro and rotawire drive were selected for percutaneous coronary intervention (pci).During the course of the procedure, eight ablations performed for the severely calcified lesion of lcx.The cine images confirmed that burr had advanced to the base of the tip of the wire.After crossing the lesion, polishing was performed, but it was stuck at the lmt.The rotational speed suddenly dropped from 200,000 rpm to 0 rpm and a stall error occurred.After stuck, the physician attempted to release stuck and to remove the burr and rotawire, but it was difficult.The drive shaft was separated when attempt was made.The physician tried to advance the 7f mach1 guide extension catheter from the disconnection point to near the base of the stuck, but encountered strong resistance and was unable to advance.The guide extension catheter was pulled, and a snare was used, but it did not go near the base of the stuck.Since the hemodynamics was stable, a system was added, a 0.014 non-boston scientific guidewire was crossed from the side of the stuck and a 3.0 x 15mm non-boston scientific balloon was dilated at the base of the stuck.The physician attempted to remove the balloon, but it could not be removed.The balloon was replaced with a 2.0 x 10mm non-boston scientific balloon, and the same balloon was crossed through the stuck area and dilated in sequence from the distal part to the stuck area a total of 8 times.The balloon was pulled out each time but could not be unstuck.The balloon was removed, but when the burr and rotawire were carefully pulled out without applying much force, it was unstuck from the lesion with no resistance and the entire system was able to be removed.Upon removal it was discovered that the rotawire was kinked and distal portion of the rotawire became separated, but there was no separated part left in the patient body.According to the physician's opinion, it may have been able to be partially unstuck by the balloon inflation.There were no device fragments left inside the body and the procedure was completed with a different device.There was no patient complication reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the sheath was detached at the burr housing strain relief and the coil was stretched and detached at the burr housing strain relief and at the burr.The three filar coil was separated and visible.In order to determine the functionality of the returned advancer, a test burr catheter was used as the returned burr catheter was not able to be used for testing.During analysis, the returned advancer was able to reach and maintain optimal rpm with no resistance or issues using the test burr catheter.Product analysis confirmed the reported separation, as the coil was stretched and detached at the burr housing strain relief and at the burr.The reported device stall could not be confirmed, as the returned advancer was able to reach and maintain optimal rpm with no resistance or issues using a test burr catheter.It was considered likely that the device stall encountered during the procedure was attributable to the damaged coil and sheath.The reported device becoming stuck within the lesion was not able to be confirmed as clinical circumstances were unable to be replicated.No other issues were identified during the product analysis.

Event Description

It was reported that the burr became stuck in the lesion, drive shaft and rotawire detached.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left main trunk (lmt) and left circumflex artery (lcx).A 1.25mm rotapro and rotawire drive were selected for percutaneous coronary intervention (pci).During the course of the procedure, eight ablations performed for the severely calcified lesion of lcx.The cine images confirmed that burr had advanced to the base of the tip of the wire.After crossing the lesion, polishing was performed, but it was stuck at the lmt.The rotational speed suddenly dropped from 200,000 rpm to 0 rpm and a stall error occurred.After stuck, the physician attempted to release stuck and to remove the burr and rotawire, but it was difficult.The drive shaft was separated when attempt was made.The physician tried to advance the 7f mach1 guide extension catheter from the disconnection point to near the base of the stuck, but encountered strong resistance and was unable to advance.The guide extension catheter was pulled, and a snare was used, but it did not go near the base of the stuck.Since the hemodynamics was stable, a system was added, a 0.014 non-boston scientific guidewire was crossed from the side of the stuck and a 3.0 x 15mm non-boston scientific balloon was dilated at the base of the stuck.The physician attempted to remove the balloon, but it could not be removed.The balloon was replaced with a 2.0 x 10mm non-boston scientific balloon, and the same balloon was crossed through the stuck area and dilated in sequence from the distal part to the stuck area a total of 8 times.The balloon was pulled out each time but could not be unstuck.The balloon was removed, but when the burr and rotawire were carefully pulled out without applying much force, it was unstuck from the lesion with no resistance and the entire system was able to be removed.Upon removal it was discovered that the rotawire was kinked and distal portion of the rotawire became separated, but there was no separated part left in the patient body.According to the physician's opinion, it may have been able to be partially unstuck by the balloon inflation.There were no device fragments left inside the body and the procedure was completed with a different device.There was no patient complication reported.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17218185
• MDR Text Key: 318025238
• Report Number: 2124215-2023-31653
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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: 0030934904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 0.014 FIELDER FC GUIDEWIRE - ASAHI; 0.014 FIELDER FC GUIDEWIRE - ASAHI; 2.0 X 10MM RYUREI BALLOON - TERUMO; 2.0 X 10MM RYUREI BALLOON - TERUMO; 3.0 X 15MM BALLOON - ZINRAI KANEKA; 3.0 X 15MM BALLOON - ZINRAI KANEKA; 7F MACH1 GUIDE CATHETER - BOSTON SCIENTIFIC; 7F MACH1 GUIDE CATHETER - BOSTON SCIENTIFIC
• Patient Outcome(s): Required Intervention