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 03/06/2014

Event Type  malfunction  

Event Description

This steerable guide catheter (sgc) is being filed for the soft tip tear noted after device removal.A soft tip tear has potential of injury.It was reported that a first mitraclip was implanted without issue.The 2nd mitraclip delivery system (10304885/02) was inserted into the left atrium, but when the medial knob was turned, the device moved lateral instead of medial so the clip was not deployed.Resistance was met during withdrawal into the steerable guide catheter (sgc) and the cds was able to be removed to the point of the clip introducer (ci).As the cds became stuck at the ci, it was decided to remove the sgc and cds together as single unit.After removal, it was noted that the sgc had soft tip damage with parallel tears.A piece of the ci was noted in the clip.There was no debris left in the patient.Access was maintained with a buddy wire.A 2nd sgc was used and 2 more clips were implanted without further incident, reducing mitral regurgitation from 4+ to 1+.There was no clinically significant delay in the procedure.The patient was extubated and left the procedure room.There was no additional information provided.

Manufacturer Narrative

(b)(4).Concomitant products: mitraclip system: 1st mitraclip implanted (cds0201, lot 10306895/25), mitraclip delivery catheter (10304885/02), support plate, lift, stabilizer.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 mitraclip cds (10304885/02) referenced is being filed under a separate medwatch mfr number.

Event Description

Subsequent to the initial medwatch filed, clarification received: the 2nd mitraclip delivery system (cds) was inserted in the left atrium.When the medial knob was turned the device moved lateral instead of medial while in the left atrium.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported damage/tears to the guide tip were confirmed via returned device analysis.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 (b)(4) microscope confirmed that there was no material missing/detached from the tip.No other damage was observed to the device.During functional testing of the 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 can include, but are 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 100% 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.Additionally, there were no non-conformances issued for this lot that would have contributed to the reported event and a review of complaint history did not indicate a manufacturing issue.The user also reported no issue while functionally inspecting the sgc during device prep, 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 guide was straightened and the clip was fully closed upon cds removal, indicating that the device was removed according to the instructions for use.In this case, since there were no issues identified with the cds or sgc in regards to retracting the clip from the guide tip, it is possible that the orientation of the clip upon removal 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 tears in the guide tip appear to be related to procedural conditions/user technique.There does not appear to be any evidence of a product quality 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: 3715613
• MDR Text Key: 4265061
• Report Number: 2024168-2014-01975
• 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: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• 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: 10303925
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2014
• 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: 45 YR
• Patient Weight: 82