MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS02ST

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The mitraclip is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is filed for the leak identified during device preparation.It was reported that during device preparation, the cap for the mitraclip delivery system (cds) lock line would not seal and saline leaked out of the lock line cap.The cap was removed and tightened, but the cap continued to leak saline.The device was not used and there was no patient involvement.A new cds was prepared and used to continue the procedure without issue.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the returned device analysis confirmed the leak was due to the polyimide tubing protruding from the bottom of the lock lever cap.The lock lever cap was unstable and not seated properly due to the exposed polyimide tubing.This in turn prevented the cap from tightening properly.A search of the complaint handling database was performed and no similar incidents were identified from this lot.A search of the lot history record for this specific lot indicated no related non-conformance records related to this failure mode.The cause of the unstable cap was possibly related to an operator error during the wrapping step of the polyimide tubing.This is believed to be an isolated event.The performance of these devices will continue to be monitored.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• 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: 5038514
• MDR Text Key: 24632048
• Report Number: 2024168-2015-04926
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: CDS02ST
• Device Lot Number: 50117U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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