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

Catalog Number SGC0301

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  Injury  

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.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This report is filed as a leak was noted in the steerable guide catheter during use.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation grade 3+.The steerable guide catheter (sgc) was advanced to left atrium (la) and was observed close to the lateral wall of the la.The sgc was retracted approximately 1 centimeter until the tip was no longer in contact with the la, per imaging.During clip delivery system (cds) insertion, there was no unusual resistance noted, however, a loss of sgc fluid column was observed and air was noted in the sgc hemostatic valve.As troubleshooting, additional aspiration was performed.The sgc air aspiration attempts were unsuccessful, however, there was no air noted in the patient anatomy.The sgc was removed and another sgc was successfully used in replacement.The same cds was advanced through the new sgc without issue and ones mitraclip was implanted, reducing the mr to <1.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).Subsequent to the initial medwatch report filed, it was confirmed that this is duplicate of an incident that was previously reported under manufacturer report number 2024168-2017-09660.Returned device analysis and investigation is documented in manufacturer report number 2024168-2017-09660.

Event Description

Subsequent to the initial medwatch report filed, it was confirmed that this event is duplicate of an incident that was previously reported under manufacturer report number 2024168-2017-09660.

• 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: 7117489
• MDR Text Key: 94850687
• Report Number: 2024168-2017-09723
• 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,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0301
• Device Lot Number: 70519U130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR