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

Catalog Number SGC0302

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report a leak in the steerable guide catheter.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.After the transseptal puncture was achieved, the dilator was retracted into the steerable guide catheter (sgc).After the dilator was retracted halfway into the sgc, the physician recognized a completely aired hemostatic chamber of the sgc.Two 50-60cc syringes of air and blood mixture were aspirated until the blood column in the chamber increased.While aspirating, the physician made sure that the three-way stopcock was closed.The procedure was continued and there were no issues with air in the devices or anatomy.It was noted that the hemostatic valve was kept closed.One clip was implanted reducing mr to a grade 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 2017 labeled.Internal file number - (b)(4).Correction: device code 2017 (failure to follow steps/instructions) added.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported for leaks from this lot.It should be noted that as per the mitraclip instructions of use states: loosen the lock lever and gripper lever caps to de-air.Do not turn lever caps more than half a turn in the open direction.All available information was investigated and the reported leak appears to be due to the user technique/error of turning the lever caps more than half a turn in the open direction during the device preparation.Additionally, the improper or incorrect procedure appears to due to the user error/failure to follow steps as the user turned the lock lever more than half to de-air the device.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: 8777331
• MDR Text Key: 150599969
• Report Number: 2024168-2019-05518
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90211U224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention