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 10/26/2020

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 available information, a cause for the reported thrombosis could not be determined. The reported patient effect of thrombus is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures. The reported additional therapy/non-surgical treatments were results of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system (cds) referenced is filed under a separate medwatch report number.

Event Description

This is filed to report thrombus during use of the steerable guide catheter (sgc) which was treated with aspiration. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4. The clip delivery system (cds) was advanced and when steering down to the valve and positioning the clip over the jet a cluster/formation was noted on the underside of the clip. Transesophageal echocardiography (tee) confirmed that it was a clot on the tip of the clip. The patient had been given heparin, but it was decided that removing the device was safest option. The clip was slowly navigated into the steerable guide catheter (sgc) to not disturb the clot. Once the clip was inside the sgc, the clot was aspirated while removing the clip. Once outside of the patient anatomy, the clot was noted on the gripper of the clip. The sgc was replaced as well as the clot could have been introduced by the sgc or left behind in the sgc. One clip was implanted, reducing mr to 1. 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: 10830106
• MDR Text Key: 215957425
• Report Number: 2024168-2020-09442
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/26/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00826U230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/12/2020 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM