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

Catalog Number SGC0702

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

The device is retained by hospital and not returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

(b)(4).This will be filed for thrombus requiring aspiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 2-3.During advancement of the steerable guide catheter (sgc) into the right atrium, thrombus was noted on the tip of the guide.The activated clotting time (act) was noted to be 233 and 2000 units of heparin were administered.The act was over 300 and the procedure continued.The dilator and guide wire were removed under aspiration.The thrombus was aspirated via the sgc.The sgc was removed and flushed, then re-inserted.The procedure continued with implant of one clip, reducing the mr to grade <1.As part of routine procedure, the septum was closed with a 25mm gore occluder.The patient was in stable condition at the end of the procedure.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.The reported patient effect of thrombosis/thrombus is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Based on the information reviewed, a cause for the reported thrombosis/thrombus cannot be determined.The reported unexpected medical intervention and required medication were 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: 12569196
• MDR Text Key: 274530576
• Report Number: 2024168-2021-08844
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10415R148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 105