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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the information provided to abbott vascular, the manufacturing records and complaint history for the reported lot.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.The reported clip getting caught on the guide tip, resulting in the reported tears in the soft tip appear to be related to procedural conditions/user technique during removal of the device.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under a separate medwatch mfr number.

Event Description

This report is filed for the 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 that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The steerable guiding catheter (sgc) and first clip delivery system (cds 50713u127) were advanced to the left atrium, but leaflet grasping was difficult due to challenging leaflet anatomy and a high transseptal puncture.The decision was made to remove the devices to perform a better transseptal puncture.During removal of the cds, the clip met resistance with the sgc tip.After removal, it was observed that the sgc tip was torn.The transseptal puncture was re-performed, and a new sgc and cds were advanced to the left atrium.Grasping was again attempted, but was difficult due to the leaflet anatomy.The decision was made to stop the procedure.No clips were implanted and the mr remained at 4+.The patient will be scheduled for an additional mitraclip procedure in the future to try again.The patient was clinically stable post-procedure and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 5167222
• MDR Text Key: 29187850
• Report Number: 2024168-2015-06252
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50713U107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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
• Patient Age: 59 YR