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

Catalog Number SGC0101

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during use with the steerable guiding catheter (sgc), the hemostatic valve would not hold fluid (leak) and aspiration was performed which is considered medical intervention to prevent air embolism.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) and dilator were advanced to the left atrium (la).When the dilator was removed from the la, it was observed that the sgc hemostatic valve would not hold fluid.Air was leaking in after dilator removal.A finger was placed back over the hemostatic valve and the sgc was taken out of the stabilizer.The device was placed lower than the patient's body.The stopcock was then re-opened and aspiration was started to ensure that air did not travel to the la.No air was noticed in the heart on echocardiogram.The sgc was removed from the body.The introducer was then inserted to advance the guide wire back into the la.A new sgc was used and 2 clips were implanted, reducing the mr was reduced to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation.The incident information provided to abbott vascular, analysis of the returned device, manufacturing records and complaint history for the reported lot were reviewed.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.The reported leak was confirmed, and appears to be related to an observed tear in the silicone valve.It is possible that the user technique used to insert/remove the dilator during procedure contributed to the silicone valve tear, which resulted in the observed leak; however, the cause of the tear cannot be confirmed.Based on the information reviewed, 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5183693
• MDR Text Key: 29711681
• Report Number: 2024168-2015-06418
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50409U121
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 68 YR
• Patient Weight: 56