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

Model Number	106553-001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of diabetes, hypertension, cerebrovascular disease and new onset of chest pain.Procedure diagnostic cath, hooked up to water, the first device sprayed water everywhere.A second product used, and it also was leaking water.A third product was used without problem.No known harm to patient.Please make note; 2 products reported on 1 report.

• Brand Name: ANGIOJET SPIROFLEX
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11146592
• Report Number: 11146592
• Device Sequence Number: 897371
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: (01)08714729889380(17)210504(10)24053520
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/07/2021
• Report Date (Section F): 01/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 106553-001
• Device Catalogue Number: 106553
• Device Lot Number: 24053520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2021
• Patient Sequence Number: 1
• Patient Weight: 88
• Date Report Sent to FDA: 01/07/2021