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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Nausea (1970); Syncope/Fainting (4411)

Event Date 06/09/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced vasovagal response, hypotension, nausea, and incontinence.A 0.018 platinum plus guidewire was advanced with a non-boston scientific (bsc) implantable pulmonary pressure monitoring sensor.During deployment, it was not certain if the sensor was fully detached from the delivery catheter.The sensor deployed at an angle causing concern that the distal portion of the sensor body was still attached to catheter.The physician was able to use the pulmonary artery catheter to remove the device from the delivery system with final placement within the pulmonary artery.Upon placing the venous sheath into the patient, the patient experienced profound vagal response.Multiple fluid boluses and multiple doses of neo synephrine were required.Subsequently, the patient frequently yawned and remained pale, hypotensive, and nauseous throughout the procedure and had incontinence while attempting to manipulate the sensor.The patient then has a second profound vagal response to sheath removal.Additional fluids and vasoconstrictor medications were administered.Eventually, the patient was stable, recovered and was released.A clinically significant delay to the procedure was reported and additional sedation was required.The procedure was completed and no further patient complications reported.

• Brand Name: PLATINUM PLUS
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15008800
• MDR Text Key: 295859160
• Report Number: 2134265-2022-07498
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other