MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE; WIRE, GUIDE, CATHETER

Model Number	2000
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Vascular Dissection (3160)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection, hypotension, and cardiac arrest occurred requiring surgery to resolve.The patient presented for a procedure to implant a cardioresynchronizer.Following cannulation of the coronary sinus, a 182cm choice guidewire was introduced.As the guidewire was being advanced, resistance was encountered and a dissection of the coronary sinus was noted.The patient then experienced hypotension and cardiac arrest.The patient was resuscitated and pericardiocentesis was performed.The patient was transferred urgently to the operating room where the bleeding was controlled.An epicardial left ventricular (lv) electrode was implanted and the patient is expected to fully recover.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).

• Brand Name: CHOICE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15080079
• Report Number: 2124215-2022-26650
• Device Sequence Number: 5049025
• Product Code: DQX
• UDI-Device Identifier: 08714729252412
• UDI-Public: 08714729252412
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 0028805126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 54 KG