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

Catalog Number SGC01ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

This report is being filed for the tear noted on the soft tip of the steerable guide catheter.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) and the clip delivery system (cds) were advanced into the anatomy; however, due to a low septal puncture, the decision was made to remove the mitraclip system to puncture the septum again in a higher position.An attempt was made to retract the cds into the sgc by pulling only the sleeve handle; however, resistance was noted.The clip was advanced and rotated with the dc handle many times under fluoroscopic guidance.After several attempts, in addition to using - deflection to close the clip more, it was possible to retract the cds into the sgc.The physician did not feel that the cds was stuck with the sgc tip, but only met resistance with it.No force was applied.After sgc and cds were removed, a tear was noted on the sgc soft tip and a bent gripper was observed on the cds.No portion of the sgc soft tip was missing.After the second puncture, a new cds and sgc were used.Two mitraclips were implanted successfully and the mr was reduced to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records/complaint history and information provided to abbott vascular.Potential causes for difficulty retracting the clip delivery system (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).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, 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.A review of the device history record revealed no non-conformances for the reported lot.Additionally, a review of the complaint-handling database identified no other reported incidents for torn material from this lot.Based on the information reviewed, there is no indication of a product deficiency.The clip delivery system (cds) referenced is filed under a separate medwatch report.

• 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: 4277288
• MDR Text Key: 5010201
• Report Number: 2024168-2014-07764
• 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
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10364185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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 -(B)(4)