MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN TRANSSEPTAL NEEDLE; TRANSSEPTAL NEEDLE/TROCAR

Model Number 00884450169704

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

Patient Problem Atrial Perforation (2511)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a pvi ablation procedure, a heartspan sheath and needle were used for trasseptal puncture.During mapping of the left atrium, it was noted that the patient's blood pressure was dropping.A pericardial effusion was noted and the case was aborted.The physician performed a pericardiocentesis, but the patient's condition did not stabilize.A surgeon then performed a pericardial window to find the perforation and was unsuccessful.A sternal incision was then performed where a perforation of the left atrial appendage was discovered and successfully closed.The patient was released from the hospital without further injury reported.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: HEARTSPAN TRANSSEPTAL NEEDLE
• Type of Device: TRANSSEPTAL NEEDLE/TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 9577988
• MDR Text Key: 189032707
• Report Number: 2529252-2020-00001
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450169704
• UDI-Public: 00884450169704
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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
• Device Model Number: 00884450169704
• Device Catalogue Number: FND-019-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention