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

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The device is not returning for analysis.A follow-up report will be submitted with all additional relevant information.The implanted mitra clip is filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).This is filed for access site bleeding.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced and placed on the mitral valve.Post deployment it was noted the clip had detached from the anterior leaflet (single leaflet device attachment (slda)).Two additional clips were implanted to stabilize the slda clip, reducing mr to 2.Post procedure, bleeding was noted at the right groin access site.A suture had been placed, but was removed and manual pressure was applied.The oozing resolved the day of procedure.The patient returned to the emergency department on (b)(6) 2021 with bleeding at the access site.Pressure to the right groin access site was applied and the event resolved on the same day.No additional information was provided.

Event Description

Subsequent to the initial report, information was received, indicating that the study physician has deemed the access site bleeding as un-related to the steerable guide catheter (sgc).Although the access site bleeding is not related to the mitraclip devices, this event has been reported; therefore, it will remain reportable.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.Based on available information, the reported bleeding is unrelated to the sgc.There is no indication of a product issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 1888 - removed.H6: health effect - impact code 4641 - removed.

• 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: 12356904
• MDR Text Key: 267828768
• Report Number: 2024168-2021-07415
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10329R326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73