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

Catalog Number SGC01ST

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

This is filed to report the hemostasis valve break that occurred with the steerable guiding catheter, which has the potential to cause or contribute to air leak/embolus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) was advanced to the left atrium.During and attempt to insert the clip delivery system (cds) into the sgc, the cds could not be inserted past the key.Four to five attempts were made, but it was observed that the sgc hemostasis valve was turning, and that the hemostasis valve and the holder could be rotated completely.The blue markers could not be aligned; therefore, the device was replaced and a new sgc was used successfully with the same cds.One clip was implanted and the mr was reduced to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guide catheter was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for analysis, and the inability to advance the clip delivery system (cds) into the steerable guiding catheter (sgc) was confirmed.Additionally, analysis identified that the bond between the valve and the guide shaft was broken.A review of the lot history record was conducted and found no exceptions associated with this lot during manufacturing.An expanded review was conducted that identified an issue potentially related to inherent variability in the manufacturing process.Further assessment of this issue per site operating procedures have been performed, and corrective and preventative 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: 4957037
• MDR Text Key: 6194790
• Report Number: 2024168-2015-04296
• 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,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/04/2015

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: 50318U114
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/31/2015
• 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