MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0705

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

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

Event Date 06/10/2021

Event Type  Injury  

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 steerable guide catheter leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.One clip was implanted, reducing mr to 1.After the mitraclip delivery system (cds) was removed, when aspirating the air from the steerable guide catheter (sgc), the doctor made a mistake in operating the three-way stopcock and air entered the sgc, requiring aspiration.There were no adverse patient effects and no clinically significant delay during 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 did not indicate a lot-specific quality issue.It should be noted that the mitraclip nt system (g4)(jpn) warns ¿heparinized saline flush should be continuous throughout the procedure.Discontinuing the flush may result in air embolism and/or thrombus formation¿.In this complaint it was reported that the user made a mistake in operating the three-way stopcock and air entered the steerable guide catheter (sgc).The investigation determined the reported leak appears to be related to the reported user error (improper or incorrect procedure or method).The user error (improper or incorrect procedure or method) was due to the user made a mistake in operating the three-way stopcock and air entered the sgc.The reported unexpected medical intervention was a result of case-specific circumstance as additional aspiration was performed due to the leak.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12071422
• MDR Text Key: 258681858
• Report Number: 2024168-2021-05442
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10210U316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 62