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

Model Number 2000

Device Problem Difficult to Advance (2920)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 07/08/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Initial reporter address 1: (b)(6).

• Brand Name: CHOICE
• Type of Device: 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
• MDR Text Key: 296368318
• Report Number: 2124215-2022-26650
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729252412
• UDI-Public: 08714729252412
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K143587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 54 KG