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

Catalog Number SGC0302

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system is filed under a separate medwatch report number.

Event Description

This is filed to report that the clip was stuck inside the steerable guide catheter (sgc) during removal, and after removal, the tip of the sgc was torn.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.There was noted tortuosity of the vena cava.One clip was successfully implanted, reducing the mr to 2.The second clip delivery system (cds) was advanced to the left atrium; however, the clip could not be opened.Standard troubleshooting was performed (i.E.Lock lever was retracted further) and then the clip could be opened.When trying to close the clip in preparation to cross the valve, the clip would not close to more than 120 degrees.It was noted that the arm positioner could not be turned further in the open direction.The clip was fully inverted and retracted into the guide, but became stuck.The sgc and cds were removed from the anatomy together.After removal, it was noted that the tip of the sgc was torn.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).Evaluation summary: the steerable guide catheter (sgc) was returned and investigated.The reported soft tip tear was confirmed.The reported difficult to remove the clip delivery system (cds) from the sgc could not be replicated in a testing environment, as it was due to patient anatomy/ procedural conditions.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported difficult to remove the cds appears to be related to user technique/procedural condition as the clip was not completely closed at the time of retracting the cds into the sgc.Additionally, the reported sgc soft tip tear appears to be related to difficulty in removing the cds.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: 6606088
• MDR Text Key: 76594142
• Report Number: 2024168-2017-04688
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/14/2017

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: 02/22/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70222U102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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