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

Catalog Number SGC01ST

Device Problems Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

This report is being filed due to the analysis of the returned device.A clip delivery system was returned with possible steerable guide catheter soft tip material, indicating soft tip damage.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.It was reported that on (b)(6) 2014, a mitraclip procedure was performed and one clip (10334635/28) was implanted reducing the degenerative mitral regurgitation (mr) grade from 3+ to less than 1+.On (b)(6) 2015, the mr grade was found to have worsened to grade 3+ due to the presence of a regurgitant jet coming from the lateral part of the previously implanted clip.The recurrent mr was caused by the continuous degeneration of the myxomatous valve and the implanted clip did not cause or contribute to the recurrent mr.The patient underwent a second mitraclip procedure.During the procedure, when the clip delivery system (cds 40909u1/44) delivery catheter handle was being advanced and retracted in the left ventricle, curving of the cds sleeve was observed.The clip was inverted and retracted back into the left atrium.Four additional attempts were made to recross the mitral valve, but due to the "snake" curve of the cds sleeve shaft, the delivery catheter shaft did not have the coaxial trajectory as it had in the beginning of the procedure and it was not possible to reach an optimal clip trajectory to cross the valve.The device was removed from the anatomy.There was no adverse patient effect or significant clinical delay in the procedure due to the device issue.Another cds was used and the procedure was completed with the implantation of one clip reducing the mr grade to 1+.

Manufacturer Narrative

(b)(4).Event description continued: it was reported that the steerable guide catheter (sgc) was not straightened during clip delivery system (cds) removal, however, there was no resistance noted and the clip arms were fully closed per fluoroscopy.Although no sgc soft tip damage was reported, the cds was returned with possible sgc soft tip material.There was no additional information provided.Concomitant products: 1 implanted mitraclip, one mitraclip delivery system.(b)(4) applied due to failure to follow instructions.Reportedly, the steerable guide catheter was not straightened during clip delivery system removal.Product performance engineering reviewed the incident information; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records and information provided to abbott vascular.In this case, although there was no reported device malfunction with the sgc, analysis of the associated cds used during the procedure identified a piece of transparent material resembling the guide soft tip between one of the grippers and clip arms within the frictional elements (fes).This is indicative of the clip getting caught on the guide tip during cds removal.Additional follow-up was sought to verify if any difficulties were experienced when removing the cds and if the clip got caught on the guide tip.In the response from the site, it was stated that the sgc was not straightened during cds removal, but no resistance was noted while the cds was being retracted and the clip did not get caught.It was confirmed that the clip arms were fully closed and fluoroscopy was used to visualize the retraction of the clip back into the sgc.In this case, while it was indicated that there were no issues while removing the cds from the sgc, the identified material appears to be consistent with the guide soft tip material and further indicates that there may have been an interaction between the clip and guide tip during the procedure; however, this cannot be confirmed based on the information provided.Additionally, the sgc was not returned for analysis, which may have further aided in the investigation.A definitive cause for the material that was returned within the clip cannot be determined.For the investigation of the returned cds associated with this event.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 lot history record confirmed this device passed all in-process and final acceptance activities, including verification that the inner diameter of the soft tip met specification.Additionally, there were no manufacturing nonconformities issued for this lot, and a review of complaint history did not indicate a manufacturing issue.The user also reported no issues with the sgc during the procedure, which is an indication that the device was functioning properly.There is no indication that the manufacture of the device contributed to the reported event.As mentioned above, additional information from the account stated that the guide tip was not straightened during cds removal.It should be noted that the mitraclip system instructions for use (ifu) states: while using imaging, slowly release sleeve deflection by turning the m/l knob and the a/p knob to the neutral position.Then slowly release guide deflection by turning the +/- knob in the (-) direction to straighten the guide tip.In this case, while there was no reported resistance during cds removal, not straightening the guide can contribute to damage to the soft tip material.The cds 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: 4621288
• MDR Text Key: 5655940
• Report Number: 2024168-2015-01508
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 02/26/2015

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: 07/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 40716U1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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