MAUDE Adverse Event Report: MEDTRONIC, INC BROCKENBROUGH NEEDLE; TROCAR

Catalog Number UNK-CV-DAN-BROCKEN

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

Patient Problem Pericardial Effusion (3271)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During an atrial fibrillation ablation procedure a pericardial effusion occurred.Following transseptal puncture with a non-medtronic introducer and a medtronic transseptal needle, an effusion was noted at the posterior wall of the left atrium.The procedure was not continued and the patient was transferred to the icu.A pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

Report was previously submitted in: mfr report number: 2649622-2019-04334, 2649622-2019-04334.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BROCKENBROUGH NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8423044
• MDR Text Key: 138890572
• Report Number: 1220452-2019-00027
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

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 Catalogue Number: UNK-CV-DAN-BROCKEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 04/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention