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

Catalog Number SGC01ST

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 similar incidents reported from this lot.All available information was investigated and the reported slippage of the steerable guide catheter (sgc) back into the right atrium (ra)appears to be due to a combination of patient morphology/pathology due to the rotated heart and user technique/procedural conditions as removal of the clip delivery system (cds) likely caused the movement.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.The clip delivery system referenced in describer event or problem and concomitant medical products is filed under a separate medwatch report.

Event Description

This event is filed for the device slippage.It was reported that during a mitraclip procedure to treat functional mitral regurgitation, it was initially thought that the clip delivery system (cds) was not steering appropriately.It was noted that the device knobs were functioning appropriately and the device moved in the expected direction; however, the device was unable to get to the valve.An attempt was made to remove the cds, but there was some difficulty noted pulling the cds back into the steerable guide catheter (sgc).The cause of the difficulty was not known.The sgc lost position and was pulled back into the right atrium.The sgc was unable to cross back through the septum to the left atrium and was removed without difficulty.A second sgc and cds were prepared and advanced into the patient anatomy without difficulty.It was noted that the second cds also seemed to have steering issues; however, it was then noted that the patient's heart was rotated.It was confirmed that the device knobs were functioning appropriately and the device moved in the expected direction correctly.Once it was realized that the patient's heart was rotated, the physician was able to steer the device and successfully implant the clip.A third cds was then advanced, with the clip successfully implanted.Two clips were implanted and the functional mitral regurgitation was reduced from grade 4 to grade 1+.No additional information was provided.

• 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: 7004332
• MDR Text Key: 92314383
• Report Number: 2024168-2017-08718
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• 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
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 61114U107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Patient Age: 28 YR
• Patient Weight: 64