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

Model Number SGC0301

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

Event Type  Injury  

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 similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak and unusable knob could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a leak and loose knob.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was prepared per the instructions for use (ifu), but it was noticed that during prep, a little more ¿¿¿ needed to be applied in order to straighten the guide.It was noted that the knob may have been a little loose.The sgc was inserted and advanced into the left atrium (la); however, it was noted that during insertion, a full turn of the ¿¿¿ knob had to be applied in order for the sgc shaft to become straight.After the sgc achieved septal access, the dilator was attempted to be removed.However, during this time, it was noted that air started to enter the sgc.Aspiration was performed, but air remained in the guide.The sgc was removed and it was expected that issues with the ¿¿¿ knob did not allow the sgc to be successfully aspirated.It was stated that no air entered the patient.A new sgc was inserted and one clip was successfully implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.No additional information was 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: 10096138
• MDR Text Key: 193067847
• Report Number: 2024168-2020-04564
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91112U231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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: 82 YR