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

Catalog Number SGC01ST

Device Problems Loss of or Failure to Bond (1068); Difficult to Insert (1316); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident information provided to abbott vascular, analysis of the returned device, manufacturing records and complaint history for the reported lot were reviewed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported difficult clip delivery system (cds) insertion was confirmed via returned device analysis; however, a definitive cause was unable to be determined.The steerable guiding catheter (sgc) hemostasis valve was examined and could be rotated around the braided shaft, indicating that the adhesive bond between the braided shaft and hemostasis valve was broken.Additionally, the hemostasis valve was torn.It is possible that the multiple forced attempts resulted in the observed hemostasis bond break and subsequent detachment as well as the tear in the silicone hemostasis valve; however, this cannot be confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This report is being filed because the steerable guide catheter (sgc) was returned with the hemostasis valve bond broken and valve torn, which has the potential to cause leaks and contribute to patient injury.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.After placement of the steerable guide catheter (sgc), the clip delivery system (cds) could not be advanced into the sgc.After several attempts, the cds was able to advance into the sgc with force, and the clip was deployed, successfully completing the procedure with mr reduced to 1.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.There was no additional information provided.The sgc was returned with the hemostasis valve bond broken and valve torn.

• 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: 5306880
• MDR Text Key: 34360773
• Report Number: 2024168-2015-07675
• 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
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50618U219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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