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

Model Number SGC0701

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

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 03/01/2021

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.

Event Description

This is filed to report perforation, intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (fmr) with a grade of 4.A guide wire was advanced with difficulty due to the anatomy and became kinked.The steerable guide catheter (sgc) was advanced in a very tortuous vein to the right atrium and before being inserted into the left atrium, the patient experienced a drop in blood pressure and rhythm changes.Medication was given for the blood pressure and no treatment was performed for the rhythm changes.The sgc then went transseptal and the hemodynamics stabilized.Next, the clip delivery system (cds) was prepped and then advanced to the mitral valve.Again, the patient's blood pressure dropped and there were rhythm changes.There was a perforation noted to the femoral vein and it may have been caused by the kink in the wire; otherwise the cause is unknown.The sgc was removed and an unspecified covered stent was used to seal the perforation.The cds was then removed with the clip still attached and the patient stabilized.Mr remains the same as no clips were implanted.The patient required 3 units of blood.Final patient outcome is good.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 the reported event.Based on the available information, a cause for the reported hypotension (treatment with medication, arrythmia (no treatment), and perforation of vessel (pti)) could not be determined.Furthermore, hypotension, arrythmia, and perforation of vessel are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The unexpected medical intervention (pti and blood transfusion) and medication required were the result of case-specific circumstances.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: 11530945
• MDR Text Key: 241564433
• Report Number: 2024168-2021-02194
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01217U114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM (CDS)
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 50