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

Model Number SGC0701

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Hemorrhage/Bleeding (1888); Hypoxia (1918); Perforation (2001); Perforation of Vessels (2135)

Event Date 05/05/2023

Event Type  Injury  

Event Description

This is filed to report soft tip damage, atrial perforation, femoral vein perforation and hypoxia requiring intervention.It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) grade 4.An xtw clip (21214r1117) was positioned on the valve.However, it was noted that the clip delivery system (cds) was curved more than 90 degrees, as the physician used an excessive amount of m knob.During establishment of final arm angle (efaa) the clip would reopen from 10 degrees to 70 degrees.The device was pulled back into the left atrium and while retracting the clip into the steerable guide catheter (sgc, 21103r1051), the physician pulled the clip hard.As a result, the clip detached from the cds but remained attached by the lock lines.The clip could not re-enter the sgc so the entire system was pulled into the right atrium and removed from the body intact.During this removal, sgc soft tip damage occurred from the clip gripper.Also, femoral vein bleeding was observed after the system was removed, and the patient became hypoxic from a right to left shunt formed from an atrial septal defect (asd).The vessel perforation was repaired with a surgical suture.Heparin was reversed and the patient was watched to make sure the bleeding stopped.This issue reportedly caused a clinically significant delay in the procedure.A femstop was placed on the right groin and the left groin was prepped and a new sgc was advanced via left femoral vein.A replacement mitraclip was successfully implanted, reducing mr to grade 1.After the procedure, an occluder was placed to treat the shunt from the asd.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip referenced in b5 will be filed under a separate medwatch report number.

Manufacturer Narrative

All available information was investigated, and the reported material split, cut, or torn (soft tip) was confirmed via returned device 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 available information, the reported torn sgc soft tip was due to procedural circumstances (i.E., forcible retraction of clip through the sgc).The reported hemorrhage and perforation of vessels associated with the bleeding at femoral vein appears to be due to the inverted clip being pulled out as the inverted clip arms would likely damage the blood vessel.The reported hypoxia was due to the asd.A cause of the reported perforation (asd) could not be determined.The reported patient effects of perforation and hemorrhage, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, hospitalization, surgical intervention, and delay to treatment/ therapy were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17004614
• MDR Text Key: 315995389
• Report Number: 2135147-2023-02320
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 21103R1051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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
• Treatment: MITRACLIP XTW
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male