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

Catalog Number SGC0302

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The clip delivery system device referenced is filed under a separate medwatch report.

Event Description

This is filed to report that the steerable guide catheter (sgc) soft tip was torn.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3 and at the same time to treat the tricuspid valve.Echo imaging was challenging.Two clips were successfully implanted, reducing mr to <1.To treat the tricuspid valve, the mitraclip delivery system (cds) (61129u123) was advanced to the tricuspid valve, however during positioning the clip got caught in the chordae, causing tissue damage.The clip was freed from the chordae and the decision was made to discontinue the procedure.The clip was in the closed position when retracting into the sgc, and the clip got caught in the guide tip of the sgc.After removal of the devices it was noted that the gripper line was broken, the grippers could not be raised.A tear was noted on the soft tip of the sgc.No clips were implanted in the tricuspid valve.There were no adverse patient effects and there was no clinically significant delay during the procedure.The patient is stable.No additional treatment is planned.No additional information was provided.

Manufacturer Narrative

(b)(4).The reported device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported tears in the soft tip resulting from the clip getting caught on the guide tip appears to be related to procedural conditions/user technique.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: 6429284
• MDR Text Key: 70970463
• Report Number: 2024168-2017-02449
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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: 10/26/2017
• Device Catalogue Number: SGC0302
• Device Lot Number: 61026U201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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: CLIP DELIVERY SYSTEM
• Patient Age: 85 YR