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

Catalog Number	FND-025-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: TRANSSEPTAL NEEDLE/TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 9292652
• Report Number: 2529252-2019-00003
• Device Sequence Number: 16610480
• Product Code: DRC
• UDI-Device Identifier: 00884450263167
• UDI-Public: 00884450263167
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE
• Outcome Attributed to Adverse Event: Life Threatening