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

Catalog Number CDS0502

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip was implanted and the clip delivery system is not returning.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report a leak.It was reported that on (b)(6) 2018, the patient, with mixed mitral regurgitation (mr), underwent a mitraclip procedure.The steerable guide catheter (sgc) was prepared for use and inserted into the patient anatomy.The clip delivery system (cds) was inserted into the sgc and it was noted that air was entering the sgc.The clip introducer had been fully advanced into the sgc.When air was noted, the physician stopped and aspirated.The sgc handle was unfastened from the stabilizer and lowered the handle below the level of the patient.No air was noted entering the patient anatomy.The clip was retracted into the clip introducer and the clip delivery system was removed from the sgc.All air was aspirated from the sgc.The clip was advanced out of the clip introducer and functionality was checked.The clip introducer was flushed again and the clip was closed and re-inserted into the introducer.Neither the clip, clip introducer nor the sgc were damaged.It was assumed that the luer lock connection of the three-way stopcock attached to the clip introducer was not properly fastened and became loose when the cds was inserted.The physician chose to proceed with the cds insertion and no further issues were noted.The procedure was completed with two clips implanted and the mr was reduced from grade 3-4 to grade 1-2.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported leak appears to be related to the loose or intermittent connection of the stopcock and the loose or intermittent connection was due to user technique as no issue was noted once the connection for the 3 way stop-cock of the clip introducer was tightened.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• 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: 7433703
• MDR Text Key: 105592807
• Report Number: 2024168-2018-02809
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71017U207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention