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

Catalog Number SGC01ST

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

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).As the device was not returned for evaluation, a failure analysis of the complaint device could not be performed.The analysis of this complaint was an assessment of the manufacturing records and information provided to abbott vascular.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 investigation determined that the torn sgc soft tip appears to be related to user error.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling.Additionally, it should be noted that the mitraclip instructions for use (ifu) states: rotate the +/- knob in the - direction until the sgc curve is substantially straightened.The mitraclip clip delivery system (cds) referenced is being filed under a separate medwatch mfr number.

Event Description

This report is being filed because the steerable guide catheter (sgc) tip was torn, which has the potential to cause serious injury if a piece of the soft tip is left behind in the patient.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3 and challenging patient anatomy due to prolapsed anterior leaflet.The clip delivery system (cds) became caught on the steerable guide catheter (sgc) tip during advancement; however, the cds was able to advance with troubleshooting and the clip was placed.During removal of the gripper line, resistance was noted and the gripper line separated.The separated gripper line was successfully removed without intervention.After removal of the devices, the sgc soft tip as noted to be torn.The procedure was completed successfully, with mr reduced to <1, no adverse patient effects, and no clinically significant delay in the procedure.There was no additional information provided.

• 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: 5157246
• MDR Text Key: 28861007
• Report Number: 2024168-2015-06140
• 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
• Report Date: 10/16/2015

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: 01/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50116U222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2015
• Initial Date FDA Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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