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

Catalog Number SGC0101

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Failure to follow steps/instructions.The device was not keyed properly during use.The customer reported the steerable guiding catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch 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.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation, grade 4+.The first clip was successfully implanted.While inserting a 2nd clip delivery system (cds) into the steerable guide catheter (sgc), the device was "miskeyed" - the cds blue line markers were not aligned to the sgc as directed in the instruction for use (ifu).The operator was unaware of the miskeying at the time.This same cds was advanced into the left atrium.During delivery catheter positioning and steering, the device was not responding as expected.It was then noted that the cds had been miskeyed.During cds retraction back into the sgc, resistance occurred.The clip had become fixed to the soft tip of the sgc and was unable to be retracted into the sgc.The cds and sgc were retracted into the inferior vena cava.Minus was applied to the sgc and the cds retracted into the sgc.Both were removed from the patient anatomy.During the removal process, the sgc soft tip had become damaged.A new sgc was placed and a 3rd cds system was used successfully implanting the clip.The mr had been reduced to grade 2.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).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 similar incidents reported from this lot.All available information was investigated and the reported soft tip tear appears to be related to user technique.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial medwatch report filed, the additional information was received: during mitraclip removal, the clip arms were fully closed and the steerable guide catheter (sgc) was initially straightened per instructions for use (ifu).The clip delivery system (cds) was retracted into the guide quickly.The clip became stuck on the guide tip.The sgc and cds were retracted into the inferior vena cava in order to free the clip from the guide.Once the clip was freed, troubleshooting measures were performed and the cds with the mitraclip were retracted into the guide catheter and removed from the patient anatomy.

• 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: 5954844
• MDR Text Key: 55149546
• Report Number: 2024168-2016-06140
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60517U136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: 1 IMPLANTED MITRACLIP1 CLIP DELIVERY SYSTEM
• Patient Age: 77 YR
• Patient Weight: 54