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

Model Number H802228240020

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/30/2021

Event Type  malfunction  

Event Description

Patient with history of diabetes mellitus, hypertension and aortic stenosis had a coronary artery bypass graft x 3 and aortic valve repair.Patient experienced recent jaw pain and chest tightness which led to his admission for cardiac catheterization and percutaneous transluminal coronary angioplasty.The tip of the rotawire¿ guidewire buckled and prolapsed back on self.Another rotawire¿ guidewire was used and the same thing happened.A third rotawire¿ guidewire was used without further issues.No known harm to patient.Please note that 2 products with different lot # are being reported to medsun.

• 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: 12165975
• MDR Text Key: 261481529
• Report Number: 12165975
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871(17)230430(10)27235513
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 27235513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 98