MAUDE Adverse Event Report: COOK INC TRANSSEPTAL NEEDLE; DRC TROCAR

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will be returned to cook.Common name & product code: although product information is unknown, the two possible cook transseptal needle part numbers are tsnc-18-71.0 and tsnc-19-56.0.Drc is the product code for both devices.Cook was initially made aware of this event by another manufacturer (abbott).Both devices are exempt.(b)(4).There has been no alleged malfunction of the device.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure in which an unknown cook transseptal needle was used, the patient developed cardiac tamponade.A transthoracic echocardiogram was performed, finding perforation of the left atrial appendage and decreased cardiac output.A pericardiocentesis was performed; however, a median sternotomy was required to stabilize the patient.The original procedure was cancelled.Per the initial reporter, the tamponade was believed to result from puncture with the needle.Additional information has been requested, but is unavailable at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report.As reported, during an unknown procedure in which an unknown cook transseptal needle was used, the patient developed cardiac tamponade.A transthoracic echocardiogram was performed, finding perforation of the left atrial appendage and decreased cardiac output.A pericardiocentesis was performed; however, a median sternotomy was required to stabilize the patient.The original procedure was cancelled.Per the initial reporter, the tamponade was believed to result from puncture with the needle.Additional information has been requested, but is unavailable at this time.Investigation - evaluation.Reviews of the documentation, drawing, manufacturer¿s instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.An ifu is provided with this device, which has warnings that include: ¿the transseptal needle must only be rotated counterclockwise to find the puncture site, in order to minimize the risk of puncturing the ascending aorta.¿ and ¿never puncture the septum without monitoring the pressure at the needle tip.¿ the ifu cautions: ¿manipulation of product requires biplane fluoroscopic control.¿ the ifu provides instruction for advancement of the device into the left atrium and instructs the user to monitor left atrial pressures before proceeding.Entry into the left atrium can be further confirmed by contrast injection and oximetry of left atrial blood, per the ifu.The needle and introducer are advanced as a unit and the needle is withdrawn into the introducer and the sheath is then advanced into the left atrium.The needle and introducer are then removed.Relative contraindications include severe deformation of the chest, congenital defects with markedly changed position of heart cavities, absence of inferior vena cava, and extreme atrial dilation.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10128674
• MDR Text Key: 194338463
• Report Number: 1820334-2020-01084
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention