MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem Perforation (2001)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Failure to follow steps.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is conservatively filed to report the perforation.It was reported that on (b)(6) 2018, the patient underwent a mitraclip procedure to treat functional mitral regurgitation (mr) of grade 3.The steerable guide catheter (sgc) was advanced.Some difficulty was noted advancing the sgc, as the septum appeared thick and stiff.Force was applied to get the sgc to cross into the left atrium.The clip delivery system (cds) was advanced and blood was noted in the endotracheal tube.It was difficult to ventilate the patient.The decision was made to abort the procedure and the mitraclip system was removed from the patient anatomy.Protamine was administered to stop the bleeding and the blood was aspiratated.Bronchoscopy was performed and noted that the blood was coming from the left bronchius.The physician suspected that during insertion of the sgc through the septum, force was applied and the stiff guide wire, positioned in the left upper pulmonary vein, punctured a small hole into the lung tissue.The patient was hemodynamically stable and was left intubated.Per physician, the lung perforation and bleeding, requiring additional medication and are not related to the mitraclip devices.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of perforation, as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.It should be noted that the mitraclip instructions for use (ifu) states: do not use excessive force to advance or manipulate the guide-dilator assembly.Use of excessive force may result in arrhythmias, vascular/or cardiac injury, including creation of a clinically significant atrial septal defect.All available information was investigated and the reported physical resistance appears to be related to patient morphology/pathology (thick and stiff septum).The patient effect of perforation appears to be related to user technique due to force applied when advancing the steerable guide catheter.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7489068
• MDR Text Key: 107440085
• Report Number: 2024168-2018-03337
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80105U234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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