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

Catalog Number SGC01ST

Device Problems Unstable (1667); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guide catheter was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed for the unstable cap on the dilator which has potential to cause or contribute to patient injury.It was reported that during device preparation, the cap of the hemostatic valve on the dilator was unable to be tightened.The device was used anyway because it was used in the tricuspid valve on the right side where pressure is low.No blood came out the proximal end of the dilator.There were no other issues encountered.The dilator was successfully removed after the steerable guide catheter was advanced to the right atrium.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and analyzed.The reported unstable dilator cap was not confirmed as the cap was able to be tightened and functioned as intended.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents reported from this lot.The mitraclip system instructions for use (ifu) states do not use the device if damage is detected.Use of damaged product may result in air embolism, vascular and/or cardiac injury.The ifu also states that the dilator is used for introduction of the steerable guide catheter into the femoral vein and left atrium.All available information was investigated and a definitive cause for the reported unstable dilator cap in this incident could not be determined.The returned device analysis confirmed that the cap functioned as expected once it was pressed back onto the rhv.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 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: 5803642
• MDR Text Key: 49906173
• Report Number: 2024168-2016-04706
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60224U148
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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