MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number	CDS0201
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (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 revealed no manufacturing nonconformities issued to this lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the information reviewed, a definitive cause for the reported leaks (gripper lever and dc handle) could not be determined.The reported failure to advance appears to be a combination of patient morphology/ pathology and user technique/ procedural conditions as the patient septum was elastic in nature and the transseptal puncture was at an angle.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
This report is filed for the air found in the device and the abnormal steering.It was reported that the clip delivery system (cds) was inserted through the steerable guide catheter.Air was noted in the handle of the delivery catheter and the gripper lever of the cds during the procedure.The air was released through the red cap on the handle and through the gripper lever cap.The drip rate was increased.No air entered the patient.The clip was unable to be steered perpendicular to the mitral valve due to the angle of the transseptal puncture.A new transseptal puncture was suggested, but the physician declined that suggestion.After 2 hours and 18 minutes of device time, it was decided to end this procedure with zero clips implanted.Mitral regurgitation grade was unchanged at 3 to 4.The patient will be brought back for another clip procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6609097
• Report Number: 2024168-2017-04737
• Device Sequence Number: 10914759
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170830(10)60829U136
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2017
• Device Catalogue Number: CDS0201
• Device Lot Number: 60829U136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 76