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

Catalog Number SGC01ST

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

This is being submitted to report the difficulty experienced during removal of the clip delivery system (cds 10509u1/16) from the steerable guiding catheter (sgc 10345115/09), which resulted in a soft tip tear.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the patient.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4 and anterior prolapse in the a2/p2 location.The steerable guiding catheter (sgc 10345115/09) and the clip delivery system (cds 10509u1/16) were advanced into the anatomy; however, the physician decided that the first puncture was not at the right position.The cds was removed, but the clip became caught on the sgc 2 times.The cds was advanced and turned slowly and became free.The cds and the sgc were then removed.A new puncture was performed.The sgc tip was noted to be damaged [torn] due to the resistance removing the cds; therefore a new sgc was used.The same cds was then re-advanced to the mitral valve with the new sgc; however, due to a huge gap between the posterior and the anterior leaflet it was difficult to grasp the leaflets.The clip was positioned and leaflet assessment was performed according to the instructions for use (ifu).The clip was then deployed; however, after retracting the gripper line, the clip detached from the anterior leaflet, remaining on the posterior leaflet (single leaflet device attachment/slda).The mr grade returned to 4, and the procedure was aborted.The patient is being considered for surgery.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The clip delivery system (40509u1/16) referenced is filed under a separate medwatch report.

Manufacturer Narrative

(b)(4).Evaluation summary: the incident information provided to abbott vascular, the manufacturing records/complaint history and the analysis of the returned product were reviewed.The steerable guiding catheter (sgc) and dilator were received consistent with the reported use of the device and post-procedure handling.The returned sgc soft tip was observed to be torn.This type of tearing is indicative of the clip getting caught on the guide tip, resulting in the clip components (frictional elements of the grippers) digging into and tearing the tip material.Potential causes for difficulty retracting the cds into the guide tip, resulting in soft tip tear/damage can be caused by, but are not limited to, manufacturing anomalies (inner diameter [id] of the tip not within specification), user technique or procedural conditions (curves on the guide during cds removal).A review of the device history record revealed no non-conformances for the lot that would have contributed to the reported event.Additionally, a review of the complaint database history indicated there have been no other incidents of soft tip tear reported for this lot.With respect to the procedural conditions and/or user technique, clip getting caught on guide resulting in soft tip damage can be influenced by the clip not being fully closed upon removal, the orientation of the clip with respect to the guide tip or curves on the sgc applied by the user.Based on the information reviewed and the condition of the returned sgc, the reported difficult to remove cds resulting in soft tip damage appears to be related to procedural conditions / user technique and not a product quality deficiency.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4137117
• MDR Text Key: 4949547
• Report Number: 2024168-2014-06400
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2014

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: 02/28/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10345115
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 10/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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
• Treatment: MITRACLIP SYSTEM,CLIP DELIVERY SYSTEM (40509U1/16)
• Patient Age: 75 YR
• Patient Weight: 53