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

Catalog Number SGC01ST

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

This is submitted to report that resistance noted with the steerable guide catheter (sgc 10316565/16) during removal of the clip delivery system.Additionally, bubbles were observed in the sgc, and the tip was torn, which are issues that have the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.It was noted that there was unusual axis of the heart.The steerable guiding catheter (sgc 10316565/16) and clip delivery system (cds 10333715/13) were advanced to the mitral valve without issue.While using the m-knob in the left atrium (la), the clip moved in the opposite direction to the valve, and was retracted.Resistance was noted while retracting the clip into the clip introducer, although the clip was fully closed, and the blue lip of introducer became compressed.The sgc was replaced because bubbles were observed in the system while retracting the clip, and it was thought that the tip of the sgc was torn.A new cds was used with a new sgc and the procedure was completed with the implantation of one clip, reducing the mr 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 device has been received.Investigation is not complete.A follow up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch report#.

Manufacturer Narrative

(b)(4) - failure to follow steps 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) soft tip was inspected and was torn.A small portion of the tip material was detached.The difficulty removing the clip delivery system (cds) from the sgc and reported leak could not be confirmed via returned device analysis.In this case, although the analysis was unable to confirm the reported leak and the difficulty removing the cds from the sgc, the discrepancy between what was reported and what was observed (no leaks identified and clip not getting caught on the soft tip) was likely due to the steps utilized by the account to remove the cds from the sgc.With regards to the reported soft tip tear, 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 tears can be influenced by 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 analysis of the returned device, the difficulty removing the cds from the sgc was due to the sgc being in neutral, and not straightened upon removal of the cds.This then resulted in the clip becoming caught on the soft tip, causing the soft tip tears.It should be noted that the mitraclip instructions for use (ifu) instructs the user to straighten the guide tip before cds removal.Based on the information reviewed and the analysis of the returned devices, the soft tip damage (tears/detachment) appears to be related to the clip getting caught on the guide tip and thus user technique/procedural conditions as the sgc soft tip was not straightened.There is no evidence of a product quality deficiency associated with the guide.A review of the device history record revealed no non-conformances for the lot.Additionally, a review of the complaint-handling database identified no other incidents reported for sgc tears and/or sgc leak for the 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: 4118189
• MDR Text Key: 4941122
• Report Number: 2024168-2014-06182
• 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: 09/02/2014

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: 10/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10316565
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 09/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 82 YR
• Patient Weight: 75