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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the loss of fluid column in the sgc.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).This was a straightforward case.The first mitraclip was implanted, but right after clip deployment, the anterior leaflet came out of the deployed clip, resulting in a single leaflet device attachment.After the clip delivery system (cds) was removed from the steerable guide catheter (sgc), the sgc hemostatic valve was noted to have a loss of fluid column as air was being aspirated after cds removal per the standard practice.The physician placed his finger over the sgc hemostatic valve, which held fluid column until the sgc was able to be removed from the patient.No air had entered the patient anatomy.A new sgc was prepared and inserted.A second mitraclip was implanted which stabilized the first clip and reduced mr.The procedure was completed with mr grade 1.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

The device was not returned.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 similar incidents reported from this lot.All available information was investigated and without a device to analyze a cause for the reported leak could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 10751882
• MDR Text Key: 213659299
• Report Number: 2024168-2020-09006
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00728U118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP CLIP DELIVERY SYSTEM
• Patient Age: 79 YR
• Patient Weight: 71