MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem Thrombosis (2100)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the leak and thrombosis.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 advanced into the right atrium (ra).Thrombus was then noted on the guide wire in the ra.The patient was on heparin and the activation clotting time (act) time was less than 250 seconds.The sgc was removed and aspiration was performed.The sgc was re-prepped and advanced into the anatomy.During retraction of the dilator, air was noted in the transparent hemostatic valve housing.It is possible that this was caused by contact with the heart tissue that created a vacuum, but this could not be confirmed.The sgc was retracted and blood was aspirated with no air aspiration.The dilator was removed, and the thumb was needed to close the hemostatic valve.After removal of the thumb, air was noted in the transparent hemostatic valve housing.The thumb was placed again to prevent new air from coming into the hemostatic valve with the sgc positioned below the left atrium and to allow blood to fill the guide lumen.Aspiration was performed.The sgc was removed and replaced with a new sgc to successfully complete the procedure.One clip was implanted, reducing mr to 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.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 air in hemostasis valve in this incident could not be determined.The reported patient effect of thrombosis could not be determined.The reported patient effect of thrombosis is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8169353
• MDR Text Key: 130498395
• Report Number: 2024168-2018-09746
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

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: 03/15/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80315U249
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STIFF EXCHANGE GUIDE WIRE; STIFF EXCHANGE GUIDE WIRE
• Patient Outcome(s): Required Intervention