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

Catalog Number SGC01ST

Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

This is filed for the tear noted on the soft tip of the steerable guide catheter which was found during returned device analysis.A torn soft tip has the remote 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 functional mitral regurgitation (mr) with a grade of 4 and a dilated left atrium (la).The trans-septal puncture was noted to be difficult due to the anatomy, and performed at the high end of 4cm.The steerable guiding catheter (sgc) was advanced to the left atrium without issue.Due to the height above the valve, the + knob was added to loose height, and the p-knob was added to successfully steer the mitraclip system to the mitral valve.During adjustment of the system, the m/l knob and a/p knob were turned.Additionally, the + knob was turned 3/4 of a turn, but a snap was heard.This did influence the axial alignment a little bit, but it was decided to implant the clip.The clip was implanted and the mr was reduced to 3.The sgc was removed and replaced.An additional clip was then implanted using a new sgc, and the mr was reduced to 2.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent returned device analysis found that a portion of the sgc soft tip was torn and missing.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the reporter was contacted and confirmed that no sgc soft tip damage was noted during the procedure or after removal from the anatomy.There was no reported resistance or difficulty noted when retracting the cds into the sgc soft tip.No additional information was provided.The incident information provided to abbott vascular, the manufacturing records, complaint history and the analysis of the returned product were reviewed.A review of the device history record identified no manufacturing nonconformities issued to the reported lot.A query of the complaint-handling database identified no previous incidents reported for cable break from this lot.Based on the reported information, the cable break and subsequent noise appear to be related to user technique/procedural conditions.The steerable guiding catheter (sgc) was returned consistent with use of the device.The sgc soft tip was observed torn.A small portion of the material was detached and not returned.The plus cable was confirmed to be broken near the skive area.The reported noise could not be replicated in a testing environment as it was likely a symptom of the cable break.Potential causes for tears and detachment of the soft tip material can include, but are not limited to, procedural conditions/user technique in regards to removing the clip delivery system (cds) during the procedure or handling, and manufacturing anomalies.With respect to procedural conditions and/or user technique, tears in the soft tip can be influenced by an interaction with the clip or inadvertent user handling.In this case, the site stated that there was no damage observed to the sgc soft tip seen under echo or after removal of the device.While it was indicated that there were no issues during device removal or damage to the sgc tip, the identified soft tip tears and detached material is indicative of a possible interaction between the clip and sgc tip; however, this cannot be confirmed based on the information provided.A definitive cause for the torn and detached soft tip material cannot be determined.There is no indication of a product quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 4869675
• MDR Text Key: 6059532
• Report Number: 2024168-2015-03590
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50202U214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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
• Treatment: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM