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

Catalog Number SGC0301

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the loss of fluid column requiring aspiration.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the mitral valve.One clip was implanted, reducing the mr to 1.During removal of the clip delivery system (cds), a finger was not initially placed over the valve of the sgc, which caused the sgc to lose fluid column.Aspirations were performed to remove the air from the column, and air did not enter the patient.The column was restored by placing thumb over the valve on guide, and the sgc was removed.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported for leak from this lot.It should be noted that the mitraclip instructions for use (ifu) instructs to cover the guide hemostasis valve with a finger upon removal.This information suggests that the user technique contributed to the reported leak.All available information was investigated and the reported loss of fluid column appears to be related to use error as it was reported that the finger was not placed over the valve upon removal of clip delivery system(cds), causing the steering guide catheter (sgc) to have loss of fluid.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: this was a mitraclip procedure to treat mixed mitral regurgitation (mr).No additional information was provided.

• 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
• MDR Report Key: 8218230
• MDR Text Key: 132105579
• Report Number: 2024168-2019-00067
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80820U111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 84