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 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip delivery system is being filed under a separate medwatch mfr number.The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during removal of the clip delivery system (cds), the clip became caught on the tip of the steerable guiding catheter (sgc) which caused the sgc tip to become torn and has the potential to cause or contribute to serious injury.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 thick.The clip delivery system (cds) was advanced to the left atrium; however, when the delivery catheter (dc) handle was advanced, the cds unexpectedly moved superior.Due to a tall and thin atrium, a lot of tension was placed on the device for positioning.After approximately 45 minutes, the lateral side of the atrium was cleared.The clip was attempted to be opened, but failed, and there was no tension in the arm positioner.Troubleshooting attempts were performed and the devices were returned to neutral, but the clip did not open.The cds was retracted into the steerable guiding catheter (sgc) without resistance; however, the clip separated but remained on the gripper lines.The gripper and lock lines were flossed in an attempt to retract the clip; however, one clip arm stuck on the sgc tip.The sgc and cds were removed to the groin, and a cut down procedure was performed to remove the clip.A new sgc and cds were used successfully.One clip was implanted, reducing the mr to 2-3.After the procedure, the clip was removed from the tip of the sgc, and the soft tip of the sgc was observed to be torn.The patient was stable post-procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The steerable guiding catheter was returned for evaluation.The reported tears of the guide soft tip material was confirmed via returned device analysis.The investigation concluded that the reported user experience was related to procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.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 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5227417
• MDR Text Key: 31512263
• Report Number: 2024168-2015-06899
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50706U221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Patient Age: 58 YR