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

Catalog Number SGC0302

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 other incidents reported from this lot.The reported sgc issue (unable to straighten guide) appears to be related to patient morphology/pathology and likely due to the small size of the heart.The reported noise was likely a result of the additional tension placed on the knob toggle subassembly when attempting to straighten the sgc shaft.Further evidence supporting this conclusion is the reported information that the device was functionally inspected, inserted into the anatomy and used during the procedure without issue, indicating that the knob was functioning until the removal process.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

Event Description

This is filed to report the failure to straighten the steerable guide catheter (sgc).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The mean pressure gradient was 2.5mmhg.The sgc and clip delivery system (cds) were advanced to the left atrium.After leaflet grasping, the gradient increased to >8mmhg; therefore, the decision was made to discontinue the procedure and not implant the clip.The grasp was released and the gradient pressure returned to 2.5mmhg.The cds and sgc were going to be removed simultaneously; however, when minus knob was turned one half to three fourths of a turn, the sgc tip did not straighten.After a second attempt, a crack was heard on the cable.The sgc and cds were able to be removed without issue.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

• 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: 6978294
• MDR Text Key: 90984995
• Report Number: 2024168-2017-08483
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• 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
• Report Date: 10/25/2017

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: 07/25/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70725U106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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