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 05/07/2014

Event Type  malfunction  

Event Description

Subsequent to the previously filed report, additional information received: the clip delivery system actuator mandrel was broken during post procedure packing of the device.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned for analysis.The device was returned with tears identified in the soft tip, which is indicative of the clip getting caught on the guide tip during removal of the clip delivery system (cds).The difficulty removing the cds from the sgc could not be tested due to the damaged condition of the returned cds.However, the soft tip tear was due to the clip becoming caught on the sgc soft tip.Potential causes for difficulty retracting the cds into the guide tip, resulting in soft tip tear/damage are, but 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).As part of the mitraclip manufacturing process, all devices are subject to visual and functional inspection to verify product quality.Review of the device history record confirmed this device passed all in-process and final inspections, including verification that the id of the soft tip met specification.There were no non-conformances issued for this lot.Additionally, a query of the electronic complaint handling database indicated there had been no similar incidents reported of for this lot.There were no reported issues 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 the procedural conditions and/or user technique, clip getting caught on guide resulting in soft tip tears 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) and the arm.When the clip is caught on the soft tip, the clip is then pushed off the soft tip during attempts to retract the cds from the sgc, which then causes the tearing.In this case, the information provided in the case details states that the cds got stuck at the sgc soft tip upon removal of the cds from the sgc.Even though it was confirmed that the clip was fully closed and the sgc was straightened, it is possible that the clip was oriented in such way that resulted in an interaction between the clip and the tip of the sgc upon retraction of the cds.This interaction would cause the difficulty removing the cds and result in tears in the sgc.Based on the information reviewed, the soft tip damage appears to be related to the clip getting caught on the guide tip and thus user technique/procedural conditions and/or post-procedure handling.There is no evidence of a product quality deficiency associated with the guide.

Event Description

This is filed as the steerable guide catheter was received for analysis with a tear to the soft tip.Although there was no initial report of a tear, if this were to recur, a soft tip tear has the potential to cause or contribute to patient injury.It was reported that during a mitraclip procedure, a little resistance was felt while inserting the clip delivery system (cds) into the key of the steerable guide catheter (sgc).The physician retracted the device and slowly readvanced it successfully into the sgc.The cds was positioned correctly in the left atrium over the mitral valve.As per the instructions for use, the cds had not been curved more than 90 degrees at any time during the device preparation or procedure.The patient anatomy was not challenging.There was no rotation on the cds handle during positioning.As the cds was advanced into the left ventricle, the cds moved much more medially and anteriorly than expected (not in the usual manner).The physician attempted to steer using many different maneuvers, but the results were always the same.It was decided to exchange the cds with another one.Upon retracting the cds by using the handle, the sgc tip was straightened by using the steering minus knob and the clip was completely closed.However, by using the handle, the clip became caught on the tip of the sgc.The clip could not be pushed off of the tip.The cds and sgc were removed from the anatomy as one unit.After removal of the device, the mitraclip procedure was aborted.

Manufacturer Narrative

(b)(4).Estimated age (date of birth 1955).Event description continued: the patient was in stable condition and the functional mitral regurgitation grade remained at the preprocedure grade of 2-3.Post procedure, an attempt to separate the two devices for shipping purposes, resulted in the cds being damaged and the clip was released from the cds attached to only the gripper and lock lines in the sgc.The cds and sgc were received at abbott vascular for analysis.Preliminary analysis found the sgc soft tip to have been torn.No additional information was provided concomitant products: mitraclip system: lift, support plate, stabilizer, clip delivery system.The steerable guide catheter was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The clip delivery system reported is being filed under a separate mfr report 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: 3845298
• MDR Text Key: 18039896
• Report Number: 2024168-2014-03557
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10296405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Patient Age: 59 YR
• Patient Weight: 67