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

Model Number 39467-175

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Vascular Dissection (3160)

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that a device entrapment and dissection occurred.The target lesion was located in the anterior tibial artery.A rotapro 1.75mm and rotawire were selected for use.During the procedure, the rotapro was advanced to the distal anterior tibial artery.The rotation started with periods of rotational deceleration.The device never stalled, however the burr stopped rotating and it could not be moved.Retraction of the device was attempted, but the burr was not able to move.The rotapro burr broke off the catheter and was stuck on the rotawire while inside the patient's leg which caused a dissection in the dorsalis pedis artery.The rotapro catheter was removed, along with the burr remaining on the rotawire.The procedure was completed with an alternative method.There were no patient complications reported and the patient remained unaffected post procedure.

Event Description

It was reported that a device entrapment and dissection occurred.The target lesion was located in the anterior tibial artery.A rotapro 1.75mm and rotawire were selected for use.During the procedure, the rotapro was advanced to the distal anterior tibial artery.The rotation started with periods of rotational deceleration.The device never stalled, however the burr stopped rotating and it could not be moved.Retraction of the device was attempted, but the burr was not able to move.The rotapro burr broke off the catheter and was stuck on the rotawire while inside the patient's leg which caused a dissection in the dorsalis pedis artery.The rotapro catheter was removed, along with the burr remaining on the rotawire.The procedure was completed with an alternative method.There were no patient complications reported and the patient remained unaffected post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device found that the coil was stretched and detached at the distal end.Functional testing was performed with a test rotawire as the rotawire used in the procedure was not returned.During functional testing, the rotawire was able to be fully inserted and removed with no resistance or issues.Product analysis confirmed the reported separation, as the coil was stretched and detached at the distal end.The reported stuck wire was not able to be confirmed, as the rotawire was able to be fully inserted and removed from the device and clinical circumstances were not able to be replicated.

• 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: 18650853
• MDR Text Key: 334656665
• Report Number: 2124215-2024-05440
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0030739565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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): Required Intervention
• Patient Sex: Male