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

Model Number H749393001250

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2020

Event Type  Injury  

Event Description

Drilling through calcified blockage when md pulled device back to give the heart a rest, device did not pull back.Burr and wire broke off and could not be retrieved.The patient required placement of iabp and emergent transfer to or for cabg.

• Brand Name: ROTAPRO¿
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10152818
• MDR Text Key: 195105379
• Report Number: 10152818
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

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: H749393001250
• Device Lot Number: 24030479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 28470 DA