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

Catalog Number CDS0501

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the inability to connect the stopcock to the flush port and the broken flush port.It was reported that during preparation of the clip delivery system (cds), it was noted that a stopcock could not be connected to the bottom flush port on the delivery catheter (dc) handle.Upon further inspection, the port was noted to be broken.The cds was not used in the anatomy and was replaced.A new cds was used to complete the procedure.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.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 similar incidents reported from the lot.All available information was investigated and a definitive cause for the reported broken flush port in this incident could not be determined.The reported issue of the stopcock not able to tighten onto the bottom delivery catheter (dc) flush port was due to the broken flush port.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8046811
• MDR Text Key: 126513178
• Report Number: 2024168-2018-08557
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80515U131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1