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

Catalog Number SGC01ST

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Physical Property Issue (3008); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guide catheter 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.

Event Description

This report is filed for the tear noted on the soft tip of the steerable guide catheter observed during device preparation.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 when the steerable guiding catheter (sgc) was removed from the sterile package, the +/- knob was not in neutral position as expected.Functional testing was performed per the instructions for use (ifu).The knob was turned 45 degrees in plus direction, but the tip of the sgc was not moving and a click was heard.Additionally, when flushing during device preparation, a tear was observed in the soft tip of the sgc.The device was not used in the anatomy and there was no patient involvement.Another sgc was used in the intended procedure.There was no clinically significant delay to the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The complaint device was returned for evaluation.The reported torn soft tip was not confirmed via returned device analysis.The reported irregular appearance (+/- knob was not in neutral position when removed from the sterile package) could not be replicated in a testing environment as it was related to procedure conditions (user observation).The reported noise could not be replicated in the testing environment as the event was a symptom of the cable break.The reported mechanical issue of steerable guiding catheter unable to curve guide was confirmed.The investigation concluded that the reported noise and mechanical issue was due to the observed cable break; however, a definitive cause for the cable break could not be definitively determined.The reported torn soft tip was user observation, related to procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 5539060
• MDR Text Key: 41777899
• Report Number: 2024168-2016-02084
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

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: 04/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50407U117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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