MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC.-ANG TRANSSEPTAL NEEDLE KIT AND STYLET HEARTSPAN; TROCAR

Catalog Number	FND-019-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
Customer reports that the patient had a pericardial effusion.They went transseptal to the left and mapped, and for a brief time they were unable to see the heart span wire, but eventually found it shortly after.They added that after this point they were getting inconsistent blood pressure readings, and the one documented after going transseptal was lower than their initial reading, and were working on getting it back to consistent.They then went to the right side to map in the rv, and when they started ablating, they were unable to reach where they needed to go.They put the catheter back into the body and at this point noticed the effusion.They stated that they ordered a stat echo, and they confirmed the effusion externally on ultrasound.They stated that they were still not getting consistent blood pressure readings.They took an arterial pressure, and this came back as low.They stated that an interventionalist performed a pericardiocentesis and drained 200cc's.They added that the blood pressure came back up and the patient is currently stable.The physician believes the issue was when they were going transseptal, the needle may have possibly punctured the ra when they could not see it.

• Brand Name: TRANSSEPTAL NEEDLE KIT AND STYLET HEARTSPAN
• Common Device Name: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.-ANG; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.-ANG; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: adrian cole ; 14646 kirby dr; houston, TX 77047 ; 8012084300
• MDR Report Key: 25243524
• Report Number: 3011642792-2026-00072
• Device Sequence Number: 18778617
• Product Code: DRC
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: FND-019-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown