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 08/07/2014

Event Type  malfunction  

Event Description

Subsequent to the previously filed report, additional information indicated that the customer was aware that the steerable guide catheter had expired on june 30, 2014, but decided to use the expired device anyway.

Event Description

This report is 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 patient.It was reported that during a mitraclip procedure, the clip delivery system (cds) and steerable guide catheter (sgc) were prepared for use as per the instructions for use (ifu).After the transseptal puncture, the sgc was inserted into the left atrium (la) as per the ifu.The cds was then inserted into the sgc.As the clip was pushed out of the tip of the sgc, the physician wanted to retract the sgc to allow more space in the la.During this maneuver, the cds delivery handle was also pulled back which caused the clip to become caught on the sgc soft tip.Despite several attempts to remove the clip (including opening the clip slightly), the clip could not be removed.It was decided to retract the sgc and cds as one unit into the right atrium.Once this was done, the clip was able to be released from the sgc tip.The cds was retracted into the sgc.Due to potential damage to the sgc tip and clip, the devices were removed from the anatomy.Another sgc and cds device were successfully used.One clip was implanted reducing the degenerative mitral regurgitation grade from 4 to 2.Once outside of the anatomy, a tear in the sgc soft tip was noted.There was no adverse patient effect or significant clinical delay in the procedure due to the device issue.No additional information was provided.

Manufacturer Narrative

(b)(4).The mitraclip delivery system (cds) mentioned is filed under a separate mfr report number.The device 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.

Manufacturer Narrative

(b)(4) - use past expiration date.The complaint device was returned and visual inspection confirmed the reported soft tip damage.There was no material missing from the torn tip and no other damage was observed to the device.The clip getting caught on the guide tip, 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.The analysis of the tear of the returned sgc is indicative of the clip getting caught on the guide tip, between the gripper (which contains the frictional elements (fe)) and the clip arm.The corresponding clip delivery system (cds) used in the procedure was returned and analysis of the device confirmed that a fe on one of the grippers was bent (this cds was filed under a separate mfr).When the clip becomes caught on the guide soft tip, in attempts to release the clip off the soft tip, the cds was advanced, pushing the clip off the soft tip.The fes on the gripper arm can became caught in the soft tip material, resulting in a tear in the guide tip and the bent fe.Evaluation summary: a review of the device history record revealed no non-conformances from the reported lot.The review of the returned product lot indicated an expiration date (use by date) of 06/30/2014 and based on the reported information the product was used one month past the labeled expiration date.It should be noted the mitraclip system instructions for use (ifu), warns the user to not use the system after the use by date stated on the package label.It was reported that the user was aware of the device expiration date but decided to use the device anyway.A review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, the clip getting caught on the guide tip appears to be related to procedural conditions/user technique, as it was reported in an attempt to make space in the left atrium, the physician unintentionally pulled back the cds which caused the clip to become caught on the sgc soft tip.There is no indication of a product quality deficiency with respect to design, manufacturing, or labeling of the device.

• 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: 4045232
• MDR Text Key: 4705403
• Report Number: 2024168-2014-05552
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• 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: MITRACLIP DELIVERY SYSTEM