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 02/20/2014

Event Type  malfunction  

Event Description

This event is being filed as the steerable guide catheter soft tip became torn during removal of the clip delivery system.A torn tip has the potential to cause or contribute to patient injury.It was reported that during a mitraclip procedure, the transseptal puncture was performed and no significant atrial septum defect was created.Due to the patient's anatomy being "twisted", the clip could not grasp the leaflets.It was decided not to continue with the procedure and remove the clip without deploying it.During removal of the clip delivery system (cds) with the undeployed clip, the clip became caught on the soft tip of the steerable guide catheter (sgc).Troubleshooting maneuvers were performed, but the clip could not be removed from the soft tip.The cds and sgc were removed as one unit from the anatomy.There was no patient injury.After removal of the devices, the sgc soft tip was observed to be torn.Post procedure, the degenerative mitral regurgitation remained at the preprocedure grade 4 and the patient was stable.No additional information was provided.

Event Description

Subsequent to the previously filed medwatch, additional information received: the tip of the steerable guide catheter was straightened and the clip was closed prior to removal.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned for investigation.The sgc was returned with the clip delivery system (cds) within it and the sgc soft tip was in the clip arms.The soft tip was observed to be torn.Microscopic inspection of the soft tip confirmed that there was no missing material.No other damages were noted on the sgc device.Potential causes for difficulty retracting the cds into the guide tip, resulting in soft tip damage/tears are, but not limited to, manufacturing anomalies, procedural conditions (curves on the sgc during cds removal) or user technique.As part of the mitraclip manufacturing process, all devices are subject to visual, dimensional and functional inspection to verify product quality.Review of the device history record confirmed this device passed all in-process and final inspections.There were no non-conformances issued for this lot that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar torn tip incidents reported for this lot.The user also reported no issue while functionally inspecting the sgc during device preparation, which is an indication that the soft tip was not damaged prior to use.With respect to procedural conditions and/or user technique, difficulty retracting the clip into the sgc can be influenced by the clip not being fully closed upon removal, the orientation of the clip with respect to the tip, or curves on the sgc applied by the user.The information provided in the case details stated that the clip had become caught during retraction into the sgc.Additionally, troubleshooting attempts were unsuccessfully made to free the clip from the tip.It was noted that the sgc was straightened and the clip was fully closed during cds removal, indicating that the user removed the device per the instructions for use.In this case, it is possible that due to the orientation of the clip with respect to the sgc tip, one of the clip arms became stuck on the tip and was therefore difficult to remove.Based on the information reviewed, it was determined that the reported tear in the sgc soft tip was caused by the attempted removal of the cds device from the anatomy, and is related to operational context / user technique.There is no indication of a product quality deficiency with respect to the manufacturing, design, or labeling of the device.

Manufacturer Narrative

(b)(4).Concomitant products: mitraclip system: lift, support plate, stabilizer, clip delivery system.The steerable guide catheter has been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system reported is being filed under another medwatch mfr number.

• 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: 3710083
• MDR Text Key: 4264927
• Report Number: 2024168-2014-01876
• 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: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10284175
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: CONCOMITANT MEDICAL DEVICES
• Patient Age: 83 YR
• Patient Weight: 79