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 Problems Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Pericardial Effusion (3271)

Event Date 12/24/2020

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 pericardial effusion.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Prior to inserting the device, it was noted that the patient originally had a pericardial effusion.The steerable guide catheter (sgc) was inserted, but while entering the left atrium (la), the patient blood pressure decreased and potentially caused an increase in a pericardial effusion.To treat the blood pressure, medication was administered.The blood pressure returned to normal; therefore, the procedure was continued.One clip was implanted, reducing mr to a grade of 1.After the procedure was concluded, thrombus was noticed on the right side of the atrial septum.It was noted that throughout the act remained above 250 throughout the procedure.To treat the thrombus, additional medication was administered.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 worsening pericardial effusion and thrombosis could not be determined.The reported hypotension appears to have been a cascading event of the reported worsening pericardial effusion.The reported patient effects of pericardial effusion, hypotension, and thrombosis are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.The reported treatment with medication(s) was a result of case-specific circumstances, as medication was administered to treat the decreased blood pressure and thrombus.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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11170129
• MDR Text Key: 226796927
• Report Number: 2024168-2021-00437
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 01013U148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 56