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

Catalog Number SGC01ST

Device Problems Mechanical Problem (1384); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2014

Event Type  malfunction  

Event Description

This mitraclip sgc (steerable guide catheter) report is being filed for the soft tip damage which has potential to result in serious injury.It was reported that the transseptal(ts) puncture was done according to the hospital standard procedure with a puncture height of 3.5-4 cm above annulus with tethering from the anterior mitral leaflet in the patient with degenerative mr, flail and prolapse from the posterior leaflet (p2).The mitraclip systems were prepared according to the instructions for use (ifu).Functionality tests were done on both the sgc and cds [clip delivery system].There were no abnormalities detected during device preparation.Insertion of both the sgc and cds were performed without incident.Steering towards the mitral valve was performed according to ifu.Unfortunately, the actual height above the valve turned out to be insufficient in order to perform a satisfactory grasp and ability to retract the dc [delivery catheter] far enough to immobilize the posterior prolapse leaflet.Unsuccessful attempts were made with the situational steering (a/p) knob to gain height.This was also due to the anatomy of the twisted heart of the patient.The decision was made to re-do the ts puncture.The clip was fully closed and locked.The gripper lever was turned outward and advanced.The dc fastener was released and a 2-3 cm separation was created to facilitate clip entry into the guide.

Event Description

Subsequent to the previously filed report, device analysis found a piece of the returned sgc soft tip was missing.The physician has been notified of this missing piece and reportedly, the patient is doing fine.This missing piece was not observed on the day of the procedure.It is surmised that the missing piece was discarded with the clip delivery system.

Manufacturer Narrative

(b)(4).Event description continued: while using imaging, sleeve deflection was released by turning the m/l [medial lateral] knob and the a/p [anterior posterior] knob to the neutral position and guide deflection was released by turning the +/- knob in the minus position.Despite these precautions and careful movements, the clip got stuck on the tip of the sgc and could not be released.The physician decided to retract the sgc carefully out of the left atrium to right atrium.There was no septum damage noted with the echocardiogram.The mitraclip system was removed from the femoral vein without complications after wiring the femoral vein first to maintain vessel access.After removal from the anatomy, it was noted that the sgc was damaged.The sgc was in neutral position meaning that +/- knob must have slipped from minus position back to neutral.The second ts puncture was performed with more height above the valve.The procedure was completed without further incident with one mitraclip reducing the mr from grade 4 to less than 1.The femoral vein was closed surgically.There was no additional information provided.The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch mfr number.

Manufacturer Narrative

(b)(4).No other external damages were noted on the device.The +/- cables were observed to be straight and centered along the length of the sgc distal shaft curve.The +/- knob was rotated towards the both the + and - directions in duplicate; the sgc curve was observed to curve as intended without issue each time.The sgc was then placed into a water bath, and a proxy cds was inserted to test for the reported event.The cds was advanced through the sgc and was retracted until the clip arms were flush with the sgc soft tip.The sgc curve was straightened, and the system (cds and sgc combined) was then retracted through the simulated inferior vena cava; the sgc was observed to be straight with no loss of curve, and the reported sgc knob issue could not be confirmed through returned device testing.Potential causes for the reported tear in the soft tip can include, but are not limited to, patient anatomy, user technique / procedural conditions (visibility during removal of the cds) or manufacturing anomalies (nonconcentric soft tip, anomalies in the soft tip).A review of the device history record revealed no non-conformances from this lot.Additionally, a review of the electronic complaint history found no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Evaluation summary: with respect to patient anatomy, user technique and/or procedural conditions, the reported tear in the soft tip may be influenced by poor visibility during cds retraction into the sgc, clip arms not being fully closed, or not fully straightening the sgc shaft during removal.Based on the information reviewed, the tear in the soft was determined to be a result of the clip being caught on the guide tip and subsequent troubleshooting attempts to remove the clip.Additionally, returned device analysis identified that soft tip material was missing; the removal of the soft tip was likely caused by the removal of the clip from the sgc soft tip.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: 3909457
• MDR Text Key: 4666526
• Report Number: 2024168-2014-04312
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10319305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: MITRACLIP CLIP DELIVEY SYSTEM