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

Catalog Number SGC0302

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system is filed under a separate manufacturing report number.

Event Description

This report is filed as there was a leak in the steerable guide catheter.It was reported that this was a mitraclip procedure treating mixed functional and degenerative mitral regurgitation (mr) grade 4.During steerable guide catheter (sgc) preparation, the sgc was unable to hold the water column.Troubleshooting and retesting was performed.The water column was then holding and the device could flush.Following, the clip delivery system (cds) was advanced to the mitral valve.Blood was noted in the delivery catheter (dc) handle.Reportedly, the lines connected to the cds and sgc which were flushing these devices were not properly connected.The lines were re-connected and flushed.The issue reportedly resolved.There was no air noted in the device, no air was noted in the lines, and no air had entered into the patient anatomy.The mitraclip was implanted, reducing the mr to grade 3.The mr could not be reduced any further as the mitral valve mean gradient pressure was deemed too high at 9mmhg after clip implantation.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.A review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and a definitive cause for the reported sgc leak (loss of fluid column) in this incident could not be determined.It is possible that the leak (loss of fluid column) was associated with the loose connection between the luer and the high pressure tubing, however, since the device was able to maintain the fluid column after troubleshooting, this cannot be definitively confirmed.The user error was associated with the high pressure tubing not being properly connected to the flush port.There is no indication of a product quality issue with respect to manufacture, design or labeling.It should be noted that in the mitraclip instructions for use states: connect high pressure tubing and a 50-60 cc syringe filled with heparinized saline to the guide flush port.It is possible that the leak (loss of fluid column) was associated with the loose connection between the luer and the high pressure tubing, however, since the device was able to maintain the fluid column after troubleshooting, this cannot be definitively confirmed.There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 7280578
• MDR Text Key: 100567952
• Report Number: 2024168-2018-01213
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70922U104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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