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 04/01/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported damage/tears to the guide tip were confirmed via returned device analysis.No soft tip material appeared to be missing from the tip.The difficulty removing the cds from the sgc could not be replicated as the returned device was not returned in a condition in which the test could be performed.A review of the lot history record revealed no] non-conformances that would have contributed to the reported event.Additionally, a review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

This mitraclip steerable guide catheter (sgc) report is being filed for the torn soft tip that has potential of causing or contributing to serious injury.It was reported that two mitraclips were implanted in the patient with degenerative mitral regurgitation (mr) reducing the mr from 4+ to 3+.A third mitraclip was inserted and grasped the leaflets, but it was noted that the mitral valve gradient increased from 2 to 3, up to 9 mm hg.The third clip was not deployed because of the high gradient pressure.The mitral valve gradient came back down to 2 to 3 after the 3rd clip was removed from the leaflets.During removal, the mitraclip delivery system became stuck at the steerable guide catheter (sgc) soft tip.After trouble-shooting maneuvers were performed, such as advancement of the sgc and changing the guide angle, the cds was successfully removed from the sgc.After removal of the sgc, multiple tears were noted on the sgc soft tip, but there were no missing pieces.The patient remained hemodynamically stable.There was no additional information provided.

Manufacturer Narrative

(b)(4).Concomitant products: mitraclip system: mitraclip (x3), lift, stabilizer, support plate.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The third clip delivery system referenced is filed under a separate medwatch mfr number.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3765368
• MDR Text Key: 11817296
• Report Number: 2024168-2014-02526
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: SGC0101
• Device Lot Number: 10303925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 81 YR
• Patient Weight: 72