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

Catalog Number TSNC-18-71.0

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during a mitral clip procedure, the patient went into asystole upon the transseptal needle puncture.The patient was defibrillated, went into a sinus rhythm, and was treated with medications.The procedure was able to be successfully completed with no further issues, and the patient remained in stable condition.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the drawings, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, and quality control was conducted during the investigation.No issues were found.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.The transseptal needle is intended for transseptal left heart access in both diagnostic and interventional procedures.The abbott mitraclip® nt clip delivery system used during the procedure is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation ((mr) = 3+) due to primary abnormality of the mitral apparatus [degenerative mr (dmr)] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.Per the transseptal needle ifu, ¿for transseptal left heart catheterization, a mullins introducer sheath assembly is recommended.If a mullins introducer is used, it is important to measure the distance between the hub of the introducer and the metallic arrow of the transseptal needle before use.The distance should be measured with the needle tip positioned just proximal to the tip of the introducer.This distance, which is usually one to two finger breadths, should be kept in mind to ensure proper fit of the assembly during the procedure.Never puncture the septum without monitoring the pressure at the needle tip.Absolute contraindications include: recent systemic embolization; left atrial myxoma.Relative contraindications include: severe deformation of the chest; congenital defects with markedly changed position of heart cavities; absence of inferior vena cava; extreme atrial dilatation.¿ per the mitraclip ifu, ¿prepare patient per institution¿s standard practice for transseptal catheterization.Access the left atrium to accommodate the guide tip using transvenous, transseptal techniques and equipment." the additional required equipment not included are the: transseptal sheath and guidewire and transseptal needle.No size or recommended manufacturer mentioned.Per the mitraclip contraindications, ¿the mitraclip® nt clip delivery system is contraindicated in dmr patients with the following conditions: patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; active endocarditis of the mitral valve; rheumatic mitral valve disease; evidence of intracardiac, inferior vena cava (ivc) or femoral venous thrombus." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Manufacturer Narrative

The patient went into asystole during transseptal puncture while contacting the septum.It was noted that the needle did not cause this event.No malfunction of the needle was encountered.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7129221
• MDR Text Key: 95233463
• Report Number: 1820334-2017-04346
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TSNC-18-71.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT MITRAL CLIP; ABBOTT MITRAL CLIP
• Patient Outcome(s): Required Intervention