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

Catalog Number SGC01ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

This report is being filed for the tear found on the soft tip of the steerable guide catheter (sgc).It was reported that during a mitraclip procedure, the preparation of the clip delivery system (cds) was performed as per the instructions for use without any problems.While the cds was in the left ventricle, the clip curved in the anterior position and it was not possible to position the clip under the leaflets.All steering knobs were in the correct position.The stored torque was released during positioning and the cds handle had not been fully extended; there was a little space.The device was removed.There were no reported problems noted with the sgc.The procedure was completed with the implantation of two clips reducing the functional mitral regurgitation grade from 3-4 to 1-2.There was no adverse patient effect or significant clinical delay in the procedure due to the device issue.The sgc was returned to abbott vascular.The preliminary device analysis found a tear in the soft tip material; there was no missing material.Additional information received indicated that the torn soft tip was not observed post procedure.After the "damaged" cds was removed, the sgc was used with two additional cds devices.There was no indication that the sgc was involved with the devices.There was no difficulty retracting the cds into the sgc.The physician does not know when the damage to the sgc soft tip could have occurred as there were no problems with the two additional cds devices.No additional information provided.

Manufacturer Narrative

(b)(4).The clip delivery system referenced was filed under medwatch report #2024168-2014-04934.Evaluation summary: there was no reported device malfunction associated with the sgc; however, the analysis of the returned device identified tears in the sgc soft tip.No other damage was noted on the device.In this case, the tearing of the sgc soft tip is indicative of the clip getting caught on the guide tip during removal of the cds, such that the clip components (frictional elements on the grippers) dig into and tear the tip material.Based on the information provided that there were no issues during removal of the cds, it is possible that the device may have been manipulated during the procedure such that the sgc soft tip interacted with the clip causing a tear; however this cannot be definitively confirmed.Although a definitive cause for the tearing of the sgc soft tip could not be confirmed, there is no evidence of a product quality deficiency associated with this device.A review of the device history record revealed no non-conformances that would have contributed to the reported event.Additionally, a review of the complaint history of the reported lot found no other incidents from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4064644
• MDR Text Key: 17990633
• Report Number: 2024168-2014-05718
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10331035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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: THREE MITRACLIP DELIVERY SYSTEMS.