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

Catalog Number SGC0701

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

Event Description

This will be filed to damage to the soft tip.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with an anterior leaflet flail.The physician advanced the clip into the ventricle (lv), but grasping was noted to be difficult.The clip was repositioned, but it was observed the posterior gripper would not lower.Troubleshooting was performed, but the issue was unable to be resolved.The physician then attempted to retract the clip back into the left atrium (la).However, resistance was felt while retracting the delivery catheter (dc) handle.The clip was able to be pulled back into the la, but at this time, a pericardial effusion was observed and the patient's blood pressure decreased, resulting in a clinically significant delay in the procedure.Pericardiocentesis was performed, but the effusion and blood pressure did not change.The clip was then attempted to be closed in an attempt to retract, but the clip was unable to close.The physician decided to retract the clip into the steerable guide catheter (sgc).However, the clip became caught on the soft tip of the sgc, causing damage to the soft tip and a bend in one of the clip arms.Both the sgc and clip delivery system (cds) were attempted to be removed together, but became stuck in the vein.At this point, the patient went into cardiac arrest and compressions were administered.The mitraclip devices were then forcefully removed from the patient in order to perform open heart surgery.It was noted the forceful removal of the device caused the clip to detach from the mandrel.Open heart surgery was attempted, but was unsuccessful as the patient bleed out and died.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 available information, the reported sgc deformation (soft tip) was due to procedural circumstances as retracting an opened clip into the sgc would likely result in sgc soft tip damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.

• 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: 17575068
• MDR Text Key: 321458239
• Report Number: 2135147-2023-03608
• 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
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• Device Catalogue Number: SGC0701
• Device Lot Number: 30313R1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 59 KG