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

Catalog Number SGC01ST

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

This report is submitted to report the use of the steerable guiding catheter (sgc)after its expiration date.There were no adverse effects to the patient.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Prior to preparation of the steerable guiding catheter (sgc) and the clip delivery system (cds), it was observed that both devices expired in may/2014.The physician was informed that the devices were expired; however, chose to use the devices for the procedure.Two clips were implanted per the instructions for use (ifu).The sgc and cds were used without issue and worked very well.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.A review of the label attached to the device history record for this lot was conducted and all labels indicated an expiration date of 31-may-2014, which is at least 12 months from the date of manufacture, as specified in the product specifications at the time this lot was manufactured.This confirms that the product was labeled correctly, and based on the reported information the product was used 3 months past the labeled expiration date.The expiration date of the product is important for the sterility, efficacy, and performance of the device.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 deficiency.A review of the device history record revealed no non-conformances that would have contributed to the reported event.Additionally, a review of the complaint history of the reported lot indicated there had been no similar device use past expiration date incidents reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4) improper or incorrect procedure or method (device use after expiry).It was reported the sgc is not returning.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 medwatch report.

• 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: 4090695
• MDR Text Key: 4716063
• Report Number: 2024168-2014-05938
• 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,Followup
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10277805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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 (X2)