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

Model Number 39467-175

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 03/08/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced a hematoma.The target lesion was located in the left anterior descending artery (lad).A 1.75mm rotapro and an opticross hd were selected for use.After a successful rotablation, an ivus was performed and it was noted that an intramural hematoma was visible at the mid to distal lad and it appeared to be well contained.The physician then covered the hematoma with a non-boston scientific drug eluting stent and it was radiographically successful.Per the physician, the hematoma was most likely a direct result from trauma to the vessel wall that occurred during rotablation.The procedure was completed and no further complications were reported.The patient did not suffer any symptoms during the procedure and is expected to fully recover.

Event Description

It was reported that the patient experienced a hematoma.The target lesion was located in the left anterior descending artery (lad).A 1.75mm rotapro and an opticross hd were selected for use.After a successful rotablation, an ivus was performed, and it was noted that an intramural hematoma was visible at the mid to distal lad and it appeared to be well contained.The physician then covered the hematoma with a non-boston scientific drug eluting stent, and it was radiographically successful.Per the physician, the hematoma was most likely a direct result from trauma to the vessel wall that occurred during rotablation.The procedure was completed, and no further complications were reported.The patient did not suffer any symptoms during the procedure and is expected to fully recover.It was further reported that intramural hematomas are known possible complications of any percutaneous coronary intervention and most likely have a slightly higher incidence during rotablation as it is a more complex procedure.The rotaburr and console performed as intended including the set speed.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16542540
• MDR Text Key: 311287759
• Report Number: 2124215-2023-11305
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0029276414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2022
• 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