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 Problem Thrombosis (2100)

Event Date 12/18/2020

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 the reported event.Based on the available information, a cause for the reported thrombosis could not be determined.The reported patient effect of thrombosis is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the thrombus requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the right atrium (ra) where a large organized thrombus was observed.The sgc was removed and thrombectomy was performed using an aspiration device.After the thrombus was removed, the sgc was reinserted and the procedure continued.Two clips were implanted, reducing mr to 1-2.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• 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: 11136306
• MDR Text Key: 225785527
• Report Number: 2024168-2021-00256
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00708U246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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
• Patient Age: 64 YR
• Patient Weight: 52