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

Catalog Number FND-025-02

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a transseptal puncture procedure, the physician accidently perforated the patient's superior vena cava [svc].A competitor's device was used to complete the procedure with no additional consequences to the patient.

Manufacturer Narrative

The suspect device was returned for evaluation.The product was examined visually.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TROCAR
• Type of Device: TRANSSEPTAL NEEDLE/TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 9292652
• MDR Text Key: 166959271
• Report Number: 2529252-2019-00003
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450263167
• UDI-Public: 00884450263167
• 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: 10/11/2019

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 Expiration Date: 05/31/2022
• Device Catalogue Number: FND-025-02
• Device Lot Number: Q1586106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE
• Patient Outcome(s): Life Threatening