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

Catalog Number SGC0101

Device Problems Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Subsequent to the initially filed report, additional information: the reporter confirmed that the detached soft tip material of the steerable guide catheter was observed to not be present in patient anatomy and no soft tip piece detached at that time and the damage was noted during packaging for return.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the incident information provided to abbott vascular, the manufacturing records/complaint history and the analysis of the returned product were reviewed.The steerable guiding catheter (sgc) was received consistent with the reported use of the device and post-procedure handling.The returned sgc soft tip was observed to be torn.This type of tearing is indicative of the clip getting caught on the guide tip, resulting in the clip components (frictional elements of the grippers) digging into and tearing the tip material.Further inspection of the soft tip material under the keyence microscope revealed that not all soft tip material was present.The reporter confirmed that the detached soft tip material was observed to not be present in patient anatomy and no soft tip piece detached at that time and the damage was noted during packaging for return.It is possible that with post-procedure handling or shipping likely resulted in a portion of the torn soft tip material to detach.No other damage was observed to the device.Potential causes for difficulty retracting the clip delivery system (cds) into the guide tip, resulting in soft tip tear/damage can be caused by, but are not limited to, manufacturing anomalies (inner diameter of the tip not within specification), user technique or procedural conditions (curves on the guide during cds removal).With respect to the procedural conditions and/or user technique, clip getting caught on guide resulting in soft tip damage can be influenced by the clip not being fully closed upon removal, the orientation of the clip with respect to the guide tip or curves on the sgc applied by the user.Based on the information reviewed and the condition of the returned sgc, the soft tip damage appears to be related to procedural conditions / user technique and not a product quality deficiency.A review of the device history record revealed no non-conformances for the lot that would have contributed to the event.Additionally, a review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

This is being submitted to report the torn soft tip of the steerable guiding catheter which was found during returned device analysis, and has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds 10354235/(b)(4)) was inserted into the guide and advanced to the left atrium with the m-knob, but it was found that the sleeve deflected superior.The cds was removed and the alignment markers were confirmed.The cds was re-advanced with markers aligned, but the sleeve still deflected superior with m-knob; therefore, the procedure was completed with the a/p knob, with no steering issue.The clip was deployed successfully and the mr was reduced to 1.There was no steering issue in the left ventricle.There were no adverse patient effects and no clinically significant delay in the procedure.The steerable guiding catheter (sgc) was returned for analysis, and found to have a torn soft tip.Additional information reported during removal of the cds, slight resistance was noted with the steerable guiding catheter (sgc).The cds was gently advanced, then pulled back in.During packaging for return, damage was noted to the tip of the sgc.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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: 4167005
• MDR Text Key: 5147033
• Report Number: 2024168-2014-06641
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: SGC0101
• Device Lot Number: 10309275
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
• Patient Age: 88 YR
• Patient Weight: 55