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

Catalog Number SGC0705

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the reported perforation resulting in hypotension appears to be related to procedural conditions associated with the atrial septal puncture and possibly exacerbated by sgc insertion.Perforation and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a perforation.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4 and restricted posterior leaflet.One clip was successfully implanted, reducing mr to a grade of <1.However, after removal of the steerable guide catheter (sgc), the patient blood pressure slight decreased and a left to right shunt was observed.Therefore, an atrial septal defect (asd) closure device was implanted.There was no clinically significant delay in the procedure.

• 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: 16383293
• MDR Text Key: 309637028
• Report Number: 2135147-2023-00537
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 20822R1087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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: IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 48 KG