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

Catalog Number SGC01ST

Device Problems Bent (1059); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during advancement of the steerable guiding catheter (sgc), the sgc became stuck.After removal, the sgc soft tip was damaged.Difficult to remove has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.During insertion of the steerable guiding catheter (sgc), the wire kinked due to the narrow vessel.The sgc could not be advanced and became stuck due to resistance with the anatomy and the guide wire.Force was used to advance the sgc, and the tip of the sgc was stressed.After multiple attempts to advance, the sgc was removed for visual inspection.During removal, resistance was again noted.There was strong bending observed, and the tip of the sgc was bent.The device was replaced, and a new sgc was used to continue the procedure.Two clips were implanted, reducing the mr to <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was 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 other incidents reported from this lot.The mitraclip instructions for use- steerable guide insertion states the following warning: do not use excessive force to advance or manipulate the guide-dilator assembly.If resistance is encountered, use echocardiography and/or fluoroscopy to assess before proceeding.All available information was investigated and the reported failure to advance the steerable guiding catheter (sgc) appears to be related to challenging vessel anatomy.The reported bent sgc shaft, resulting in difficulties removing the device, appears to be a result of user error.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

• 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: 5795848
• MDR Text Key: 49628056
• Report Number: 2024168-2016-04593
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 51020U215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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