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

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and without a device to analyze a definitive cause for the reported leak could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the leak on the steerable guide catheter.It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr).During device preparation of the steerable guide catheter (sgc), a noticeable, but subtle leak was noticed at the flushport of the hemostatic valve.The connection was confirmed tight, but the leak was still present.There was no loss of fluid column from the hemostatic valve.This sgc was not used in the patient and was replaced with a new sgc.The procedure continued with a mitraclip xtr that was able to grasp the leaflet, but the gradient increased to 12 mm hg and when repositioned, gradient went to 9 mm hg.This xtr was removed, undeployed.A mitraclip ntr was inserted and grasped but gradient went to 9 mm hg.The ntr was removed undeployed.The procedure was completed with no clip implantation due to the gradient.The gradient returned to its baseline of 1 mm hg when the clips were removed, undeployed.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

• Brand Name: MITRACLIP SYSTEM 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: 10207234
• MDR Text Key: 197305108
• Report Number: 2024168-2020-05402
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00323U147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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 Age: 63 YR
• Patient Weight: 64