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

Catalog Number SGC0302

Device Problems Bent (1059); Mechanical Problem (1384); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2017

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 not returned for analysis.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 physical resistance during sgc advancement through the septum appears to be related to patient morphology/pathology and due to the very strong septum.The reported mechanical issue with the knob and bent shaft are likely secondary effects of the issues experienced while crossing the septum and there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report that the steerable guide catheter (sgc) would no longer deflect.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was advanced into the anatomy.Due to a strong septum, resistance was noted while attempting to cross with the sgc.A balloon was used to dilate the septum and the sgc was re-advanced.Strong force was used and the sgc was able to cross after approximately 3 hours.After the septum was crossed, it was found that the sgc would no longer deflect with the use of the +/- knob.The sgc was removed and noted to be bent.A new sgc was used to complete the procedure.One clip was implanted, reducing the mr to <1.There was no adverse patient sequela or a 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: 6734970
• MDR Text Key: 80898376
• Report Number: 2024168-2017-06142
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• 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
• Report Date: 07/21/2017

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: 02/24/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70223U133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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