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

Model Number SGC0701

Device Problem Difficult to Advance (2920)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a pericardial effusion, perforation intervention and hospitalization.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.A non-abbott device was used for transseptal puncture.As the steerable guide catheter (sgc) was advanced, there was some resistance, and a pericardial effusion was noticed.The team examined the heart and observed the sgc crossing outside of the right atrium and then entering back into the left atrium.The cardiac surgeon was called, and a sternotomy was performed.The cardiac surgeon found a small perforation in the right atrial appendage from unknown origin.The clip procedure resumed, and one clip was successfully deployed.Mr was reduced to grade 1.The surgeon examined the heart and could not find a perforation.The sternotomy was closed.The following day, imaging showed trivial effusion and trivial mr.The patient was recovering.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 incidents reported from this lot.Based on available information, the reported difficult to advance associated with resistance noted during attempted transseptal crossing appears to be due to the sgc advancing through waterson¿s groove instead of the fossa ovalis.The cause of the reported perforation associated with the sgc crossing waterson¿s groove and the raa perforation could not be determined.The cause of the reported pericardial effusion could not be determined.The reported patient effects of pericardial effusion and perforation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention and hospitalization 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
• 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: 16529586
• MDR Text Key: 311150922
• Report Number: 2135147-2023-01150
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20830R1031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 90 KG