MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Model Number SGC0701

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 05/24/2023

Event Type  Injury  

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 similar complaints reported from this lot.Based on the available information and without the device to analyze, the reported difficulty inserting the device into the anatomy was due to patient anatomy.The reported tissue injury and hemorrhage appear to be due to the mitraclip procedure.The reported effect of tissue injury and hemorrhage are listed in the instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported medical intervention was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip devices referenced in b5 is filed under separate medwatch report number.

Event Description

This is filed to report difficult to insert the device into the femoral vein, causing bleeding and tissue damage, requiring intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+.During insertion of the steerable guide catheter (sgc) into the right femoral vein, the physician felt resistance, tried to push a little harder, and felt the two perclose "pop".Two more perclose were used to attempt to minimize the bleeding and was able to continue with the procedure.An xt clip (30324r1033) was introduced into the sgc.When using the m knob, the sleeve shortened as expected.When the physician tried to pull the handle back, there was friction.The handle was pushed in just a few millimeters, which freed up the friction feeling and was able to pull back the handle as desired.During grasping attempts, it was unable to be determined whether the anterior gripper (tactile marker) would lower.Troubleshooting steps were performed, but still unsure if it was working.It was decided to pull the clip back into the left atrium.However, the clip could not go back into the left atrium, then it jumped suddenly into the left atrium.Clip appeared to be stuck to the anterior leaflet or chordae prior to it "jumping".It was then noted that the anterior gripper was not working.After taking this clip out of the patient, the team determined the gripper line must have gotten tangled in either chordae or the leaflet, causing the gripper line to snap when trying to pull the clip back into the atrium.No cord or leaflet damage was noted on echo at this time.An xt clip (30316r1110) was implanted with no reported issue.Another xt clip (30324r1034) was implanted to further reduce mr.The clip was introduced into the sgc.After using the m knob, when the physician tried to pull the handle back, there was friction.The handle was pushed in just a few millimeters, which freed up the friction and was able to pull back the handle as desired.The clip was implanted with no further issues.Another xt (30324r1037) was used to further reduce the mr.The same issue as the first and third clip was experienced.Friction was felt when pulling the handle.The handle was pushed-in just a few millimeters, which freed up the friction and was able to pull back the handle as desired.The clip was deployed, reducing mr to grade 1+.During evaluation of the result, the last implanted clip (30324r1037) started to look crooked on fluoroscopy, and mr returned to grade 3+.The clip looked stable.In the physician¿s opinion, the leaflet was pulled so tight with tension that the clip arm tip tore through the leaflet, causing the mr to increase.Upon completing procedure, sgc was removed.Extensive bleeding at the groin site occurred, and 6 more perclose were used to repair the right femoral vein.On (b)(6) 2023, patient had improvement in symptoms, and was able to ambulate around the nursing unit later that day, and the mr looked much improved on tte.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 similar complaints reported from this lot.Based on the available information and without the device to analyze, the reported difficulty inserting the device into the right femoral vein was due to the difficult patient anatomy.The cause of the reported instructions for use (ifu) deviation was due to user pushing the sgc (steerable guide catheter) when resistance was noted.Therefore, an in-service will be sent to the account to address the deviation from the instructions for use and its associated potential adverse events.The reported tissue injury and hemorrhage are cascading effects of the reported ifu deviation.The reported effect of tissue injury and hemorrhage are listed in the ifu document and are known possible complications associated with mitraclip procedures.The reported medical intervention was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.2017 added to h6.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17126739
• MDR Text Key: 317207407
• Report Number: 2135147-2023-02575
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 30127R1069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 63 KG