MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the device was used past the expiration date.It was reported that the mitraclip procedure was performed on (b)(6) /2021 to treat functional mitral regurgitation with an mr grade of 4+.The user was informed that the steerable guide catheter (sgc) was expired.The expiration date for the sgc was 7/23/2021.Despite knowing the sgc was expired, the sgc was still used for the procedure.Two clips were implanted, reducing mr to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.It should be noted that per the instructions for use states, mitraclip g4 system, ce ¿do not use the mitraclip g4 system after the ¿use by¿ date stated on the package label, and never reuse or re-sterilize the system.Use of expired, reused, or re-sterilized devices may result in infection¿.In this case, it was reported that the user used the device despite knowing the sgc was expired which is a deviation from instruction for use.The investigation determined the reported improper or incorrect procedure or method (use after expiration) was due to the user error of using the device despite knowing the steerable guide catheter/sgc was expired.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12500068
• MDR Text Key: 273631788
• Report Number: 2024168-2021-08322
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00723U235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1