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

Catalog Number SGC0101

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

Additional information subsequent to the initial report: the first cds (10307415/04) used is the cds that could not be inserted, and was not deployed.The second cds (10304645/14) became caught in the chordae.It was noted that the images were not great, but they were not unacceptable, and the clip was implanted successfully.The third cds (10308585/05) used became caught in the chordae during positioning.The images were not great with this cds either, but they were not unacceptable.It was confirmed that difficulty was noted aligning the clip back into the sgc, but the clip was re-aligned and the cds was removed easily.The clip arms were fully closed.Additionally, the guide straightened during cds removal.No damage was noted to the sgc.There was no difficulty with advancement of any cds, only the previously reported insertion difficulty with the first cds.The valve had several secondary and tertiary chords that were near the grasping region.For the clips which were caught in the chordae, there was no unexpected movement or steering with the cds.Substantial clip arm orientation adjustments were made to the device during removal from the chordae.The physician does not feel that the device contributed to the clip getting caught in chordae.After the procedure was completed, it was observed that the hemostatic valve was loose.It was confirmed that no pressure was applied to the hemostasis valve during preparation or the attempts to insert the cds.No additional information was provided.

Event Description

This is filed to report the tear in the steerable guiding catheter tip which was found during returned device evaluation.Soft tip tear has the potential to cause or contribute to injury.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.There was a medial jet and a lateral jet, with a posterior flail.The first clip delivery system (cds 10304645/14) was prepared, inserted and advanced without issue.During the attempt to deploy the first clip in the medial jet, the clip became caught in the chordae.Troubleshooting maneuvers were performed per the instructions for use (ifu), and the clip was able to be freed from the chordae.The clip was implanted successfully and the mr was reduced to 3+.The second cds (10307415/04) was then attempted to be inserted into the same sgc, but the cds could not be inserted.A new cds (10308585/05) was then inserted into the same sgc (10306635/14) without issue.The clip was inserted and advanced without issue.The leaflets were grasped, but the clip could not be positioned lateral enough to reduce the lateral jet.During the attempt to position, the clip became stuck in the chordae.Troubleshooting maneuvers were performed per the instructions for use (ifu), and the clip was able to be freed from the chordae.The cds was removed and no further treatment was performed.The mr grade remained at 3+, with one clip implanted.It was noted that the lateral chordae was ruptured, but the physician is unsure if this occurred during the attempt to place the last clip, or if the rupture was pre-existing.

Manufacturer Narrative

(b)(4).Continued case description: the patient was confirmed to be clinically stable post-procedure.There was no clinically significant delay in the procedure.Subsequently, the sgc was returned and visual analysis of the device found a tear in the soft tip.The reporter was contacted and stated that during removal of the clip delivery system (cds 10308585/05) resistance was felt with the steerable guiding catheter.The clip was re-aligned and the cds was removed easily.No damage had been noted to the sgc post-procedure.No additional information was provided.Concomitant products: mitraclip system: lift, support plate, stabilizer, mitraclip delivery system (x3).The mitraclip was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The two clip delivery systems referenced are reported in separate mfr report numbers.

Manufacturer Narrative

(b)(4).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) was returned consistent with the reported use of the device.The sgc soft tip was identified to be torn at 1, 2 and 6 oclock with a piece of tip material detached between the 1 and 2 oclock position, which is indicative of a clip getting caught on the guide tip during removal, as reported during removal of the third cds used in this case.There was a kink noted in the curve of the distal shaft approximately 2cm from the sgc radiopaque tip ring.However, this damage was not reported and likely occurred during the removal attempts of the cds and/or handling during packaging for shipment back to abbott vascular for analysis.The kink in the shaft does not appear to be related to the reported difficulties.There was no other external damage observed to the sgc.In an effort to simulate the clinical condition, the returned sgc was inserted into a water bath with a simulated inferior vena cava.The guide was straightened and an attempt was made to insert the returned cds into the guide, but the key on the steerable sleeve met resistance with the keyway of the guide and the cds could not advance any further.Thus, the reported difficulty inserting the cds was confirmed.During testing, it was noted that the hemostasis valve bond between the valve and guide shaft was broken and the valve could be rotated around the guide shaft.After manually rotating the valve approximately 5 degrees counter-clockwise, the cds was then able to be inserted into the sgc without issue.If was further identified that after removal of the cds, the steerable sleeve key on the cds was observed to be offset by 90 degrees.The key was loose and could be rotated around the sleeve.In this case, based on the analysis findings, the difficult cds insertion may have been attributed to the loose sleeve key of the cds and/or the loose hemostasis valve bond.Potential causes for the loose hemostasis valve bond can include, but are not limited to, user technique/procedural conditions or manufacturing anomalies.As part of the mitraclip manufacturing process, all devices are subject to 100 percent 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 guide met specification.The process monitoring data for this device was reviewed in the area of key force testing and the bond strength met specification.Additionally, there were no non-conformances issued for this lot and a review of the complaint handling database for this lot identified no other incidents reported from this lot.The user also reported no issues while functionally inspected the sgc during device preparation, which is an indication that the device was functioning properly prior to use.With respect to procedural conditions and/or user technique, a loose hemostasis valve can be attributed to device handling the result of inadvertently applying a rotational torque force on the luer, causing stress to the bond between the guide shaft and the hemostasis valve.In this case, since there were no difficulties inserting the other cds devices into the guide during the procedure, it is likely that the hemostasis valve became loose from inadvertently handling after the third cds was successfully used, and likely did not cause the difficulty inserting the second cds.Based on the information reviewed, the reported loose hemostasis valve appears to be related to user technique/procedure conditions, and the difficult cds insertion may have been related to the loose sleeve key identified on the returned cds.In regards to the difficulty removing the cds from the guide, although no damage was reported to the sgc, the tears identified in the soft tip are indicative of the clip getting caught on the guide tip during removal of the cds.Potential causes for difficulty retracting the clip into the guide tip can include, but are not limited to, procedural conditions (curves on the guide during cds removal), user technique, such as clip not being fully closed upon removal and/or the orientation of the clip with respect to the guide tip, or manufacturing anomalies.Based on the information reviewed, 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.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: 3854288
• MDR Text Key: 4557016
• Report Number: 2024168-2014-03643
• 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: 04/04/2014

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: 09/30/2014
• Device Catalogue Number: SGC0101
• Device Lot Number: 10306635
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2014
• 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: 77 YR
• Patient Weight: 79