MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER CATHETER, STEERABLE

Catalog Number SGC0701

Device Problems Difficult to Flush (1251); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001. The device was received, but the investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system that was used on this patient is being filed under a separate medwatch report.

Event Description

This is filed to report the air in the device. It was reported that this was a mitraclip procedure in the patient with grade 4 degenerative mitral regurgitation (mr). The steerable guide catheter (sgc) was advanced into the patient. When the physician inserted the sgc and tried to aspirate per the standard instructions, it took much longer than expected to aspirate. The tip of the sgc was confirmed on imaging to be free of any structures. Air was entering the sgc as seen by air in the fluid column but no air was introduced into the patient. It did not take more force to aspirate from the sgc, but it did take longer than usual. The same sgc was used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: MITRACLIP G4 STEERABLE GUIDE 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: 9405116
• MDR Text Key: 177761962
• Report Number: 2024168-2019-14069
• 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: 01/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/30/2020
• Device Catalogue Number: SGC0701
• Device Lot Number: 91001U209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial