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 04/30/2014

Event Type  malfunction  

Event Description

This is being filed as the steerable guide catheter was returned to abbott vascular with a torn soft tip.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 during a mitraclip procedure, the clip delivery system (cds) was introduced into the anatomy via the right groin access.After the clip was introduced into the left ventricle and when closing the clip after the first grasp of the leaflets, a "hard resistance in the arm positioner" was felt and a squeaking like noise was heard.The clip was opened and inverted and was retracted back into the left atrium for repositioning.Once the clip was in the left atrium, the clip appeared to be out of alignment and the cds appeared to be curved.When the clip arm were attempted to be closed they remained in opened to approximately 40 degrees and could not be completely closed.Again a "hard resistance" was felt at the arm positioner; the arm positioner was turned to the hard stop.To try to close the clip arms further, the actuator knob was pulled which pulled the mandrel (inner rod).The clip arms were closed a bit more, but not enough.An attempt to invert the clip was performed, however, at this point, the clip could not be inverted or closed any further; the arm positioner could not be turned any further in the closed position.Unsuccessful attempts were made to retract the clip into the steerable guide catheter (sgc) in the open position.An unsuccessful attempted was made to try to lasso the clip with a snare and tighten the clip arms to close it.

Manufacturer Narrative

(b)(4).Event description continued: during an attempt to remove the clip outside of the sgc, the clip became stuck on the septum with one arm in the left atrium and the other in the right.The sgc was pulled into the right atrium leaving the clip attached to the septum and the shaft of the cds.Using the left groin, another access site was used to advance another sgc into the right atrium and through the same transseptal puncture next to the clip attached to the septum.The clip was successfully deployed along with another clip.The mitral regurgitation grade was reduced from 3 to 1 with the implantation of two clips.After the removal of the sgc and cds from the left groin, a patent foramen ovale closure system was used.The first part of the closure system was deployed on the left atrium side and the clip that was stuck on the septum was released from the cds.The second part of the closure system was then deployed, closing the transseptal puncture and securing the clip.The first sgc and cds were then removed from the right groin.There was no adverse patient sequela.The patient was clinically stable post procedure.No additional information was provided.Subsequently, the sgc was received at abbott vascular.Preliminary device analysis revealed the sgc had a torn soft tip.There was no missing soft tip material.The reporter was contacted and additional information received indicated that during the attempt to remove the opened clip through the sgc, the clip became caught on the sgc soft tip.The sgc soft tip was not examined post procedure and the damage had not been observed at that time.No additional information was provided.The device investigation of the steerable guide catheter is not yet complete.A follow-up report will be submitted with all additional relevant information.The mitraclip referenced is filed under a separate medwatch mfr number.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned for evaluation.The soft tip of the sgc was noted to be torn and this type of tear is indicative of the clip getting caught on the sgc 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 (b)(4) microscope confirmed that there was no material missing/detached from the tip.No other damage was observed to the device.Reportedly, upon retracting the clip delivery system (cds) from the sgc, the clip became caught on the soft tip of the sgc; however, the soft tip was not inspected post procedure and the damage was not observed.Functional testing of the difficulty retracting the clip into the guide resulting in soft tip tears could not be tested as the clip was deployed during the procedure and was therefore not returned with the cds.Potential causes for difficulty retracting the cds into the sgc 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 sgc 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 that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.There were no reported device 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 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 sgc 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, it was confirmed that during the attempt to remove the opened clip through the sgc, the clip became caught on the sgc soft tip.Since in this case, the clip could not be fully opened or closed, attempts to retract the cds from the sgc caused the clip to get caught on the soft tip of the sgc.This interaction between the clip and the tip of the sgc upon retraction of the cds caused the difficulty removing the cds, which then resulted in tears on the sgc soft tip.Therefore, based on the information reviewed, and the analysis of the tears, the soft tip damage appears to be related to procedural conditions.There does not appear to be any evidence of a product quality deficiency associated with the sgc.

• 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: 3882121
• MDR Text Key: 4510035
• Report Number: 2024168-2014-03914
• 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: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• 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: 10299855
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2014
• 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
• Treatment: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM