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 07/10/2014

Event Type  malfunction  

Event Description

This is filed as a tear in the steerable guide catheter (sgc) soft tip occurred.Although there was no adverse patient effect, a torn soft tip has the potential to cause or contribute to patient injury.It was reported that prior to the mitraclip procedure, the transseptal puncture was uneventful.The sgc and clip delivery system (cds) were introduced into the anatomy through the right femoral vein.The anatomy was not challenging; there was no resistance met during the advancement of the cds through the sgc.When the clip was in the left atrium and approximately 3cm out of the tip of the sgc, the cds was pulled back to avoid tissue contact.Although there was no resistance felt while pulling back the cds, the device was retracted with force and the clip became stuck on the tip of the sgc.In an attempt to remove the clip from the tip, the grippers were raised, the clip was opened and the device was attempted to be advanced, but the clip remained attached to the tip.The sgc and cds were removed as one unit from the anatomy.Once outside of the anatomy, the tip of the sgc was observed to have been lacerated by the clip.The removal of the devices was uneventful without causing an atrial septal defect.The groin was closed with a z-stitch.The procedure was continued through the left femoral vein and a new transseptal puncture was performed.New sgc and cds devices were used and 3 clips were implanted reducing the functional mitral regurgitation grade from 3-4 to 2.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is being filed under a separate medwatch mfr number.

Manufacturer Narrative

(b)(4).The sgc was returned and analysis confirmed the reported sgc soft tip damage, which 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.Further inspection of the soft tip material under the keyence microscope confirmed that there was no material missing/detached from the tip.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).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.Evaluation summary: a review of the device history record revealed no non-conformances for the lot.A review of the electronic complaint-handling database identified no other reported incidents for sgc soft tip torn from this lot.Based on the information reviewed, there is no indication of a product 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: 3970886
• MDR Text Key: 4630748
• Report Number: 2024168-2014-04890
• 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: 07/10/2014

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: 11/30/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10322145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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