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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

This report is being filed as the steerable guide catheter tip became damaged during the procedure.A damaged tip has the potential to cause or contribute to patient injury.It was reported that during a mitraclip procedure, when the clip was in the left atrium, the clip would not open at all.Trouble shooting maneuvers were performed (unlocking/locking clip, releasing curves on the device) with no success.While removing the clip delivery system (cds) the soft tip of the steerable guide catheter became damaged.The clip did not get stuck on the tip, but the removal was a little difficult.The damage to the tip could not be described further.The cds did not have any problems during preparation.The cds shaft was not curved more than 90 degrees during preparation or procedure.The procedure was completed with the use of two additional cds devices.The degenerative mitral regurgitation grade was reduced from 4+ to 2+ with the implantation of the two clips.Post procedure the patient was clinically stable.No additional information was provided.

Event Description

Subsequent to the previously filed medwatch report, additional information received indicated that there was no resistance noted during the insertion and advancement of the clip delivery system (cds).During the insertion of the cds, the steerable guide catheter (sgc) +/- steering knob was set at neutral.When the troubleshooting maneuvers were performed, the arm positioner was set to neutral.There were no turns on the cds handle.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned.Visual inspection identified tears in the sgc soft tip material, confirming the reported damage.This type of tearing is indicative of the clip getting caught on the guide 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 keyence microscope confirmed that there was no material missing from the tip.No other damage was observed to the device.During functional testing of the clip delivery system (cds), there were no issues were noted while removing the cds from the sgc; however, the difficulty retracting the clip into the guide could not be properly replicated a testing environment due to the damaged condition of the returned sgc.Potential causes for difficulty retracting the cds into the guide tip, resulting in soft tip damage/tears are, but not limited to, manufacturing anomalies (inner diameter of the tip not within specification), procedural conditions (curves on the guide 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, including verification that the inner diameter of the soft tip met specification.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 soft 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 guide can be influenced 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 information provided in the case details stated that the clip did not get stuck on the tip, but the removal of the cds was a little difficult and the soft tip of the sgc became damaged.In this case, it is possible that the clip may have slightly opened during troubleshooting maneuvers and therefore was not fully closed or 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 soft tip.Based on the information reviewed and the analysis of the returned devices, the reported difficulties appear to be related to procedural conditions/user technique.There does not appear to be any evidence of a product quality deficiency.A review of the device history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar incidents reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).Concomitant products: mitraclip system: lift, support plate, stabilizer, clip delivery system.The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is being filed under a separate 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: 3671535
• MDR Text Key: 4239665
• Report Number: 2024168-2014-01428
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: SGC0101
• Device Lot Number: 10306655
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 89 YR
• Patient Weight: 69