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

Catalog Number SGC0101

Device Problems Kinked (1339); Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The mitraclip clip delivery system referenced is filed under a separate manufacturing report number.

Event Description

This report is filed for the tear noted on the soft tip of the steerable guide catheter.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.This was a mitraclip procedure performed on (b)(6) 2016 to treat degenerative mitral regurgitation (mr) with a grade of 4 via direct right atrial access, mini-thoracotomy.The patient anatomy was challenging.The steerable guiding catheter (sgc) was advanced into the right atrium; it was noted on fluoroscopy that the distal portion of the sgc was kinked.During retraction of the clip delivery system (cds) into the sgc, the clip got caught on the steerable guide tip.Standard trouble shooting was performed to remove the cds from the tip of the sgc and a tear was noted on the sgc tip.The sgc was replaced with another sgc.The same cds was advanced to the mitral valve, steering was challenging due to the patient's rotated heart and the clip got caught in the chordae.Standard troubleshooting was performed to free the cds and the clip was successfully deployed in a1/p1 leaflet segment.At the end of the procedure mr remained unchanged at grade 4 with the one clip implanted.The patient is stable.There were no adverse patient effects and no clinically significant delay in the procedure.The patient will have a consult for possible mitral valve surgical repair or replacement.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection and functional testing were performed on the returned device.The reported steerable guide catheter (sgc) torn soft tip and kink in the guide shaft were confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported clip getting caught on the guide tip, resulting in the identified tears in the soft tip appears to be a procedural condition of the kinked guide.Furthermore, challenging patient anatomy likely contributed to the kink observed in the guide after the sgc was inserted into the anatomy.It should be noted that the mitraclip instructions indicates that the left atrium should be accessed using transvenous, transseptal techniques.The challenging patient anatomy appears to have necessitated the right atrial access mini-thoracotomy.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: 6235472
• MDR Text Key: 64606077
• Report Number: 2024168-2017-00233
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60620U139
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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
• Treatment: MITRACLIP CLIP DELIVERY SYSTEM
• Patient Age: 64 YR
• Patient Weight: 58