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

Model Number	00884450169704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Perforation (2511)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: TRANSSEPTAL NEEDLE/TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 9577988
• Report Number: 2529252-2020-00001
• Device Sequence Number: 14178744
• Product Code: DRC
• UDI-Device Identifier: 00884450169704
• UDI-Public: 00884450169704
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 00884450169704
• Device Catalogue Number: FND-019-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention