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

Catalog Number SGC01ST

Device Problems Problem with Removal of Enzymatic Cleaner (1213); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

This is filed to report that the steerable guiding catheter (sgc) was used after the expiration date.It was reported that this was a mitraclip procedure was performed on (b)(6) 2015, to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) and the clip delivery system (cds) were observed to be expired (expiration: 05/2015) by the account; however, the devices were intentionally used in the procedure.There were no issues during use with the mitraclip system.One clip was implanted and the mr was reduced to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records/complaint history and information provided to abbott vascular.The device was not returned for analysis; therefore, the expiration date on the specific product label could not be confirmed; however, a review of the label for this lot was conducted and all labels indicated an expiration date (use by date) of 31-may-2015.This confirms that the product was labeled correctly, and based on the reported information the product was used 3 days past the labeled expiration date.It should be noted that in the mitraclip system instructions for use (ifu) warns the user do not use the system after the use by date stated on the package label, and never reuse or re-sterilize the system.In this case, the reported device expiration issue is associated with the physician using the device past the expiration date; there is no indication of a product quality issue.A review of the device history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database identified no other incidents for the reported lot for the reported device used after expiration.Based on the information reviewed, there is no indication of a product issue.The mitraclip clip delivery system referenced is filed under a separate medwatch mfr number.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4857517
• MDR Text Key: 15896615
• Report Number: 2024168-2015-03451
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 1036665502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM