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

Model Number SGC0701

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) leak. It was reported that this was a mitraclip procedure to treat a degenerative mitral regurgitation (mr) with grade 4. The clip delivery system (cds) was advanced to the mitral valve and the clip was implanted successfully. The steerable guide catheter (sgc) was noted to have a leak as when aspiration was performed air was noted in the valve. There was no air introduced into the patient and there was no further aspiration required. The physician commented that during removal of the cds, the atraumatic tip was not fully inside the clip introducer and this could have damaged hemostatic valve of the steerable guide catheter (sgc). A new sgc had to be used to continue with the procedure. A second cds was advanced and the clip was deployed without issue. Two clips implanted, reducing mr to <1. There was no adverse patient effect and not clinically significant delay in the procedure. 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: 10174454
• MDR Text Key: 195899111
• Report Number: 2024168-2020-05178
• Device Sequence Number: 1
• Product Code: DRA
• 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

• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/03/2020
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00204U118
• 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: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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: 06/19/2020 Patient Sequence Number: 1

Treatment

1 IMPLANTED CLIP; CLIP DELIVERY SYSTEM