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

Catalog Number SGC0101

Device Problems Device Slipped (1584); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2015

Event Type  malfunction  

Event Description

This report is being filed for the tear noted on the soft tip of the steerable guide catheter which was found during returned device analysis, and 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 mixed mitral regurgitation (mr) with a grade of 4.The septum was noted to be floppy and there was challenging leaflet anatomy.The clip delivery system (cds) was advanced to the mitral valve leaflets.While translating the cds forward in the left ventricle, the clip would dive anterior.The steerable guiding catheter (sgc) was torqued posterior, and the cds was re-oriented in the left atrium (la).The cds was then advanced to the lv more lateral, but the cds moved more anterior.An attempt was made to grasp the leaflets, but this was not successful.All knobs were released, but the cds and sgc were then in the right atrium (ra).It was decided to replace the device.The clip was closed, the sgc was straightened, and the cds began to be retracted into the sgc, but resistance was noted.The cds was advanced with resistance, and resistance was noted with retraction.Troubleshooting was performed, and the clip was opened.The clip was closed and the cds was removed.A tear was noted in the septum, and a piece of the septum was observed on the clip.A thrombus was noted on the la side of the septum, and there was a 13mm atrial septal defect.No treatment was performed for the tear or thrombus.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The procedure was aborted and the patient was confirmed to be stable.No additional information was provided.Subsequent analysis of the returned sgc, on 04/09/2015, revealed the soft tip was torn.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 returned for analysis.The soft tip was noted to be torn; however, all soft tip material was present.The device was inserted into a water bath.The cds was advanced without issue.System curves were applied, and no issues were observed.The curves were then removed from the device, and no device slippage was observed; therefore, the reported event could not be confirmed.During device removal, no interaction between the cds clip and the sgc soft tip was observed.The tears in the sgc soft tip are associated with the interaction between the sgc tip and the clip; therefore, the soft tip tears are a result of procedural conditions.Potential causes for the reported device slippage can include, but are not limited to, patient conditions (frail anatomy), user technique / procedural conditions (imaging), or manufacturing anomalies.With respect to the patient conditions, procedural conditions and/or user technique, the device slippage may be influenced by poor / weakened patient anatomy such as floppy septum or enlarged puncture.In this case, it is possible that due to the patient anatomy (floppy septum), the device slipped back into the right atrium once the curves were released; however, a definitive cause could not be determined.Based on the information reviewed and the analysis of the returned device, a conclusive cause for the device slippage could not be determined; however, there is no indication of a device quality deficiency.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint-handling database identified no other incidents for the reported lot.Based on the information reviewed, there is no indication of a product deficiency.The clip delivery system referenced, is filed under a separate medwatch mfr number.

• 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: 4731842
• MDR Text Key: 5707733
• Report Number: 2024168-2015-02373
• 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
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: SGC0101
• Device Lot Number: 41215U109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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 SYSTEM, CLIP DELIVERY SYSTEM
• Patient Age: 83 YR