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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem Bradycardia (1751)

Event Date 02/10/2021

Event Type  malfunction  

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 other incidents reported from this lot.All available information was investigated and a cause for the reported leak could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report leak.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (dmr) with a grade of 4.Prior to the procedure and during prep of the steerable guide catheter (sgc) the sgc failed prep as it could not hold the fluid column.It was attempted twice but still failed so a new sgc was prepped and was able to be used.The clip delivery system (cds) was then advanced to the mitral valve and when it was placed, the mean pressure gradient increased to 7 mmhg and heart rate was 60.The clip was moved and placed again, and again the mean pressure gradient went to 7 mmhg, heart rate 60.Finally it was decided to invert the clip and remove it from the anatomy.No treatment was performed for the bradycardia.A new nt cds was advanced and implanted and the mean pressure gradient was 5 mmhg and mr was reduced to 2.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11387890
• MDR Text Key: 240316089
• Report Number: 2024168-2021-01514
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00928U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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