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

Catalog Number SGC01ST

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The mitraclip clip delivery system referenced is filed under a separate medwatch report.

Event Description

This report is filed for difficulty removing the steerable guide catheter and for a tear noted on the soft tip of the steerable guide catheter.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 this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The mitraclip delivery system (cds) was advanced to the mitral valve leaflets, however, positioning the cds was difficult due to the tilted, rotated heart.Leaflet grasping was performed with the clip placed in different positions, however; mr could not be reduced.The clip was not implanted.Attempts were made to retract the closed clip into the steerable guide catheter (sgc); however, the clip got stuck at the tip of the sgc.Resistance was felt during removal of the sgc and cds at the groin area.The clip was unlocked, opened and retracted into the sgc to aid in removal.The sgc and cds were both removed from the patient anatomy without further issue.Once outside the patient anatomy a tear was observed on the tip of the sgc, however, there was no loss of tip material.The procedure was aborted.No clips were implanted.The mr remains 3-4.There were no adverse patient effects and no clinically significant delay in the procedure.The patient is stable.No additional treatment has been planned for the patient.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported difficulty removing the device and soft tip tears appear to be a result of procedural conditions and secondary effects to the clip being caught on the soft tip.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6055392
• MDR Text Key: 58600779
• Report Number: 2024168-2016-07284
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60526U220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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 DELIVERY SYSTEM