MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

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

Patient Problem Thrombosis (2100)

Event Date 02/19/2020

Event Type  Injury  

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 this event.A definitive cause for the thrombosis could not be determined.The patient effect of thrombosis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.A conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is being filed to perform thrombosis and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.It was noted restricted posterior and dilated left atrium.The transseptal puncture was performed and then the steerable guide catheter (sgc) was advanced to the left atrium; however, thrombus was observed on the sgc tip.The patient was given an additional dosage of heparin and aspirations were performed to remove the thrombus.The sgc was retracted back to the right atrium, and the thrombus was resolved.The procedure was aborted and the patient is stable.No clips were implanted, and mr is 3.There was no clinically significant delay in the procedure.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9819406
• MDR Text Key: 183166113
• Report Number: 2024168-2020-02271
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91211U134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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
• Patient Outcome(s): Required Intervention