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

Catalog Number SGC0101

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is being filed under a separate medwatch mfr number.

Event Description

This is filed to report difficulty retracting the clip into the steerable guide catheter (sgc)and difficulty removing the sgc at the groin which has potential to cause or contribute to injury.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was deployed and the mr was reduced to >1.There was still a small jet; therefore, the decision was made to treat it with an additional clip.The second clip delivery system (cds) was advanced without issue; however, while steering to the valve with the m-knob, the device went upwards.The cds was retracted but became caught on the steerable guiding catheter (sgc) soft tip.Both devices were pulled to groin, and resistance was felt.A contrast injection was performed to see what the resistance was.It was found that the access site had been made through an internal vein instead of the femoral vein.The clip was advanced forward, and then successfully retracted in the sgc.The devices were then removed without resistance.Outside the anatomy, the devices were inspected and it was found that the alignment marker appeared to be 20 percent off.The mr was reduced to <1 with the one clip implanted.No further clips were attempted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The complaint device was returned for evaluation.The reported difficulty removing the device could not be tested during returned device analysis, but a tear in the soft tip material was identified.The investigation concluded that the reported user experience of difficult to remove the sgc from the anatomy was related to user error, as the access site was made at the internal vein instead of the femoral vein, while the soft tip tear was related to user technique/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 other incidents reported from this lot.It should be noted that the mitraclip instructions for use instructs to insert the guide-dilator assembly over the stationary guide wire into the femoral vein.In this case, it was reported that the device access site was the internal vein instead of the femoral vein.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: 5429526
• MDR Text Key: 38154234
• Report Number: 2024168-2016-00777
• 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,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50311U216
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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: 68 YR
• Patient Weight: 136