MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problem Entrapment of Device (1212)

Patient Problems High Blood Pressure/ Hypertension (1908); Ischemia (1942)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2023 used as approximate event date as actual event date is unknown.

Event Description

It was reported that the burr became stuck in lesion and patient experienced myocardial ischemia and unstable blood pressure.The severely stenosed with delayed flow target lesion was located in the severely calcified mid left anterior descending artery.A rotablator was selected for use.During the procedure, the burr suddenly entrapped in the culprit lesion, leading to broad anterior myocardial ischemia and unstable blood pressure.Intra-aortic balloon pumping was immediately inserted via right femoral artery, and double guide catheter technique was adopted via left femoral artery.A new guide wire in the second system was crossed beside the stuck burr, and small size balloon could cross and was dilated, which lead to successful removal of the stuck burr.Finally, two drug-eluting stents were implanted, and the procedure was successfully conducted.No further patient complications were reported.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LTD; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17714291
• MDR Text Key: 323001832
• Report Number: 2124215-2023-49074
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/08/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 76 YR
• Patient Sex: Female