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

Catalog Number SGC0705

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

Patient Problem Perforation (2001)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip referenced in is filed under separate medwatch report number.

Event Description

This is being filed to report that after removal of the steerable guide catheter (sgc), a left to right shunt at the septum was observed.It was reported that the first mitraclip procedure was performed on (b)(6) 2021 to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing mr to <1.After the procedure, a left to right shunt was observed due to the steerable guide catheter (sgc) diameter and elevation of left atrial pressure of reduced left ventricular function.The atrial septal defect (asd) was closed using an asd occluder.Approximately, 7 -10 days after the procedure, the patient presented with with worsening heart failure and increased mr grade of 3.On (b)(6) 2021, a second procedure was performed, one clip was implanted, reducing mr from 3 to 2.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have influenced the reported events.Based on this information, the reported perforation was due to procedural conditions.The reported perforation (asd) is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported medical intervention was a result of case specific circumstances as the atrial septal defect (asd) was closed using an occluder.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12267934
• MDR Text Key: 264766699
• Report Number: 2024168-2021-06756
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 01017U152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 46