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

Catalog Number SGC0302

Device Problems Break (1069); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2017

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 received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This event is filed for the inability to straighten the device.It was reported that on (b)(6) 2017, the patient, with degenerative mitral regurgitation, underwent a mitraclip procedure.During preparation of the steerable guide catheter (sgc), the "+/-" knob was rotated approximately 3/4 of a turn to straighten the sgc before advancing the device into the patient anatomy.A "tearing" noise was heard and the sgc was pulled back.The "+/-" knob was re-tested and would only respond when turned in the "+" direction.There was no response when turned in the "-" direction and a cable break was suspected.The sgc was replaced with a second device.One mitraclip was implanted and then a second clip delivery system (cds) was advanced.During advancement, the clip was caught in the sub-valvular apparatus, but was easily removed using standard troubleshooting maneuvers.The second clip was implanted.After implantation of the second clip, a new lateral jet was noted and the mr remained at grade 4.Additionally, the pressure gradient, which was at 1 pre-procedure, was at 4-5; therefore, the physician did not implant any additional clips.The pressure gradient remained at 4-5 post procedure.Although the pressure gradient remained elevated, the physician does not consider this as mitral stenosis.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guiding catheter (sgc) and the reported mechanical issue and cable break was confirmed.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported noise could not be replicated in a testing environment as it was likely a symptom of cable break and a cascading effect.A definitive cause for the reported cable break in this incident cannot be determined.It is possible that there were procedural interactions which resulted in increased tension on the device and contributed to the cable break; however, this cannot be confirmed.The reported mechanical issue and noise appears to be related to the cable break.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

• 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: 6415191
• MDR Text Key: 70433666
• Report Number: 2024168-2017-02280
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2017
• Device Catalogue Number: SGC0302
• Device Lot Number: 61118U119
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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