MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240020

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 06/01/2022

Event Type  Death  

Event Description

An elderly female with known severe coronary artery disease (cad) & severe aortic stenosis who was recently evaluated by cardiothoracic surgery and not felt to be a surgical candidate for coronary artery bypass graft surgery (cabg) & aortic valve replacement (avr) - elected plan for percutaneous coronary intervention (pci) of right coronary artery (rca) and left anterior descending artery (lad) and continued transcatheter aortic valve replacement (tavr) evaluation to follow.Patient was in cath lab for percutaneous coronary intervention (pci), allegedly rotoblator burr got stuck in the body and upon removal of the burr, post-antiogram noted free floating contrast outside the coronary artery.Patient deteriorated and code was called.During the code the rotawire was removed without the distal radiopaque portion attached.Due to this patient's physiology (ie calcified lesions, stenosis and notable tortuosity extending into the abdominal aorta), extensive cardiac history and co-morbidities; it is not easily concluded that this device event ultimately contributed directly to the patient's demise.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14652900
• MDR Text Key: 293699334
• Report Number: 14652900
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2022

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: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 27984732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 32120 DA
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: White