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

Catalog Number SGC01ST

Device Problems Loss of or Failure to Bond (1068); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the broken hemostasis valve bond, found during returned device analysis, which has the potential to compromise the fluid path integrity and can lead to an air embolism in the patient.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.After placement of the steerable guide catheter (sgc), the clip delivery system (cds) could not be advanced into the sgc.After several attempts, the cds was still unable to advance into the sgc; therefore, the cds and the sgc were removed.The same cds was used with a new sgc to successfully complete the procedure, with mr reduced to 1-2.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.There was no additional information provided.Subsequent analysis of the returned device found the sgc hemostasis valve bond was broken.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guiding catheter (sgc) was returned for analysis, which identified that the hemostasis valve could be rotated around the braided shaft, indicating that the adhesive bond between the braided shaft and the hemostasis valve was broken.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 similar incidents reported from this lot.An expanded review was conducted that identified an issue potentially related to manufacturing.It was concluded that the most probable cause was a combination of inherent process variation during manufacturing and variation in physician technique leading to high forces being placed on the bond and a subsequent bond failure.Corrective and preventive actions to address this issue are in the process of being implemented.The performance of these devices will continue to be monitored.

• 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: 5306726
• MDR Text Key: 34370515
• Report Number: 2024168-2015-07672
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112239
• 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: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50326U201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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