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

Catalog Number SGC01ST

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the incident information provided to abbott vascular, the manufacturing records, complaint history and the analysis of the returned device were reviewed.Device analysis revealed the soft tip of the steerable guide catheter (sgc) was torn, confirming the reported tears.A portion of the soft tip material where it was torn was detached and was not located.Potential causes for difficulty retracting the clip into the guide tip, resulting in the reported soft tip tears 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, difficulty retracting the clip into the guide tip and associated 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.Based on the information reviewed, the difficulty removing the cds/clip caught on guide tip and tears in the soft tip appear to be related to user technique/procedural conditions.There does not appear to be any evidence of a product quality deficiency.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint handling database identified no other incidents reported soft tip tears from this lot.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

This is submitted to report the resistance noted with the steerable guiding catheter (sgc 10338515/07) during removal of the clip delivery system (cds), which resulted in a torn sgc soft tip.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3.The first clip delivery system (cds 40414u2/16) was inserted into the steerable guiding catheter (sgc 10338515/07) and advanced to the mitral valve.An attempt was made to steer the clip with m-knob, but the clip moved upward.The cds was retracted, but the clip became stuck on the tip of the sgc.The clip was freed, and removed from the anatomy.The grippers were noted to be bent; therefore, this cds was replaced.A new cds (40414u2/22) was inserted into the same sgc, but the same movement was observed while turning the m-knob.The cds was removed, and it was found that the tip of the sgc was torn.A new sgc was used to continue the procedure.The cds (40414u2/22) was re-advanced and the clip was deployed.The mr was reduced to 1-2.The next cds (40418u1/16) was advanced to the mitral valve, but there was no sufficient mr reduction with the clip, so the clip was not deployed.During retraction of the cds, the clip became stuck, but it is unknown what the clip was stuck on.During an attempt to free the clip, it jumped very lateral in the height of the leaflets, and was freed.The cds was removed successfully.The patient was in a stable condition post-procedure and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant product: mitraclip clip delivery system (x2).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The two cds (40414u2/16 and 40418u1/16) referenced are being filed under separate medwatch reports.

• 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: 4173585
• MDR Text Key: 16215289
• Report Number: 2024168-2014-06708
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/24/2014

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: 01/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10338515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Patient Age: 70 YR
• Patient Weight: 70