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 10/07/2014

Event Type  malfunction  

Event Description

This report is filed for the tear noted on the soft tip of the steerable guide catheter.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The first clip delivery system (cds 40616u1/01) was inserted into the steerable guiding catheter (sgc), with proper marker alignment; however, steering issues were observed; therefore, the cds was removed and replaced.A new cds was used successfully and the clip was implanted.The mr was reduced to 2.A second cds (40624u1/12) was then advanced to the mitral valve; however, the clip became caught in the chordae.Troubleshooting steps were performed and the clip was freed from the chords, and implanted.The second clip was not able to be placed in the residual jet that was close to the first clip; therefore, the mr increased from 2 to 3.There were no adverse patient effects and no clinically significant delay in the procedure.Preliminary analysis of the returned steerable guiding catheter (sgc), performed on 11/17/2014, found a soft tip tear.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: mitraclip system, clip delivery system (cds 40616u1/01), 1 implanted mitraclip (40624u1/12).The clip delivery system (40624u1/12) referenced is filed under a separate medwatch report.Evaluation summary: the incident information provided to abbott vascular, the manufacturing records/complaint history and the analysis of the returned product were reviewed.The analysis of the returned steerable guiding catheter (sgc) identified that the soft tip material was torn, which is indicative of the clip getting caught on the sgc tip.There was no material missing from the tip.Potential causes for tears in 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 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 due to it 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.In this case, while this cannot be confirmed, it is possible that there was a slight interaction between the clip and guide tip during removal which resulted in the tearing identified in the soft tip.Although this type of damage is consistent with an interaction between the clip and guide tip, a definitive cause for the tears cannot be determined based on the information reported.There is no evidence of a product quality deficiency.A review of the device history record identified no non-conformances issued to the reported lot.Additionally, a review of the complaint handling database identified no other reported incidents for the 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: 4322361
• MDR Text Key: 5211962
• Report Number: 2024168-2014-08094
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10352975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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