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

Catalog Number SGC01ST

Device Problems Bent (1059); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

This report is being filed for the tear noted on the soft tip of the steerable guide catheter (sgc 40911u201).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 two mitraclips were implanted on (b)(6) 2013 in the patient with mitral regurgitation (mr) reducing the mr from 4 to less than 1.In april 2014, the patient was noted to have recurrent mr of 3.Regurgitant jets were noted lateral to the implanted mitraclips due to further degeneration of the mitral valve.A second mitraclip procedure was performed on (b)(6) 2015.After the mitraclip steerable guide catheter (sgc 40911u201) and clip delivery system (cds 41003u253) were advanced to the left atrium, it was noted that the transseptal puncture was too low and anterior.The sgc and cds were removed from the anatomy.The clip got stuck on the steerable guide catheter (sgc) soft tip when the clip delivery system (cds) was being retracted from the anatomy.The cds was repositioned and successfully removed through the sgc; however, the tip of the sgc became torn from the interaction with the clip.The sgc was noted to have an s-curve on the shaft and the soft tip was oval shaped.The sgc shaft curve was thought to be due to the left groin access.The cds was tested outside the anatomy and it was noted that the clip would not open.A second transseptal puncture was performed and cds 41001u237 was deployed with an mr of 1.

Manufacturer Narrative

(b)(4).Event description continued: after the sgc and cds were removed from the anatomy, the anterior medial leaflet came out of the deployed mitraclip (41001u237) and mr returned to 3.The single leaflet attachment was thought to be due to the fragile leaflets/degenerated tissue and not enough leaflet tissue to grasp.A new sgc and cds 41111u256 were inserted and the clip grasped both leaflets.Before deployment of clip 41111u256, a duct occluder was inserted, then clip 4111u256 was deployed, followed by deployment of the duct occluder, but mr remained the same.The patient was extubated.No additional information was provided.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 two clip delivery systems referenced are filed under a separate medwatch mfr numbers.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported bend in the steerable guide catheter (sgc) shaft, ovaled-shaped tip and tears in the soft tip material were confirmed via returned device testing.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this 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, it is likely that there was increased tension on the sgc due to a combination of the left groin access and difficulties experienced while positioning the mitraclip system due to the low transseptal puncture, such that the sgc shaft became bent.The reported difficulty removing the mitraclip delivery system was likely due to the user not fully closing the clip arms upon the initial retraction attempt, such that the clip got caught on the tip.Then as troubleshooting steps were performed to free the clip from the tip, this likely caused the tip to become ovaled and torn.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: 4601525
• MDR Text Key: 5464162
• Report Number: 2024168-2015-01389
• 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: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 40911U2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Treatment: IMPLANTED MITRACLIPS (X2)