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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

This report is filed for steerable guide catheter soft tip damage found on preliminary visual analysis of the returned device.Although there was no adverse patient effect, soft tip damage has the potential to cause or contribute to patient injury.It was reported that the first clip delivery system (cds) was inserted and advanced through a neutral steerable guide catheter (sgc), without resistance, in a patient with degenerative mitral regurgitation (mr) of 4+.The device was properly straddled, in the left atrium, without issue.The m knob was turned, however, the clip moved in the opposite direction than intended, towards the left pulmonary vein.Reportedly, there was no unusual curve on the sgc.The p knob was turned to attempt clip implantation, unsuccessfully.Resistance was noted during removal of the undeployed cds.The resistance was with the sgc.A second cds advanced the same sgc in the same fashion as the first.Again, upon m knob application, the cds moved towards the pulmonary vein.This time, the p knob was applied, successfully implanting the clip.A third cds was advanced in the same fashion as the other two.Reportedly, the m knob worked successfully and the third clip was implanted and device removed without issue.The two implanted clips reduced the mr to 2+.There was a procedural delay, loading another cds, but this delay was reportedly, not clinically significant.There were no adverse patient effects.

Manufacturer Narrative

(b)(4).Subsequently, preliminary visual analysis of the returned steerable guide catheter revealed soft tip tear/damage.The reporter was contacted who stated the damage was not noted during or after the procedure but possibly occurred during removal of the undeployed cds.There was no additional information provided.The first clip delivery system mentioned is filed under a separate manufacturer report number.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.Visual inspection identified a tear in the steerable guide catheter (sgc) soft tip material.All soft material was accounted for and no material missing/detached from the tip.Functional testing was performed and no resistance or clip getting caught in soft tip was noted.There was no other damage observed to the device.Potential causes for difficulty retracting the clip into the guide tip, resulting in soft tip tears can include, but are not limited to, anatomical morphology/pathology, procedural conditions (curves on the guide during cds removal), user technique or manufacturing anomalies.Review of the device history report (dhr), confirmed this device passed all in-process and final inspections.Additionally, there were no non-conformances issued for this lot that would have contributed to the reported event and a review of complaint history did not indicate a manufacturing issue.The user also reported no issues while functionally inspecting the devices during preparation, which is an indication that the soft tip was not damaged prior to use.With respect to the patient condition, procedural conditions and/or user technique, difficulty retracting the clip into the guide may be influenced by anatomical morphology/pathology, the user not fully closing the clip or straightening the guide upon removal, or excessive force or range of motion while manipulating the devices.In this case, it is likely that the orientation of the clip resulted in an interaction between the clip and the tip of the sgc, resulting in difficulty removing the cds and soft tip tears.Based on the information reviewed and the analysis of the returned devices, the reported difficulty removing the cds and damage to the sgc soft tip appears to be related to procedural conditions/user technique.There does not appear to be any evidence of a product quality 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: 3995335
• MDR Text Key: 4780552
• Report Number: 2024168-2014-05039
• 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: 07/16/2014

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: 04/30/2015
• Device Catalogue Number: SGC0101
• Device Lot Number: 10358815
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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 CLIP DELIVERY SYSTEM (X3)
• Patient Age: 79 YR