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 06/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This report is being filed on the steerable guide catheter based on returned device analysis finding of hemostasis valve bond breakage, which has potential for the device to leak and introduce air into the anatomy.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr).The steerable guide catheter ((b)(4)) was prepared and advanced into the left atrium.Introduction of the first clip delivery system (cds) into the sgc, via the clip introducer, was without issue.Great resistance was met however, while advancing the cds into the sgc.The cds was unable to advance past approximately 5 centimeters due to resistance.The cds was removed and another cds was attempted.The same advancement issue was noted.The sgc was replaced and the first, previously attempted cds advanced the new sgc successfully.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided.Subsequently, the sgc was returned to abbott vascular for analysis.Device analysis, on 06/30/2015, revealed the hemostasis valve could be rotated around the braided shaft indicating and the adhesive bond between the braided shaft and hemostasis valve was broken.

Manufacturer Narrative

(b)(4).The reported difficulty inserting the clip delivery system (cds) into the steerable guiding catheter (sgc) was confirmed, and was attributed to a broken bond between the hemostasis valve and the braided guide shaft.The reported incident information provided to abbott vascular, as well as manufacturing records, complaint history, and the analysis of the returned product, were reviewed.There were no non-conformances during the manufacture of this lot that contributed to the event.No other similar complaint incidents were reported for this lot.The engineering department has investigated the issue, and determined that the most probable root cause of the broken bond was a combination of inherent variation in the hemostasis valve attachment process and variation in physician technique leading to high forces being placed on the bond.Corrective and preventive actions to address this issue are currently being determined, and will be implemented per local site operating procedures.

Manufacturer Narrative

(b)(4).

• 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: 4933367
• MDR Text Key: 22657603
• Report Number: 2024168-2015-04099
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 08/18/2015

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: 03/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50318U117
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• 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