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

Catalog Number CDS0502

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This report is filed due to a leak noted during use.It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 3-4.During clip delivery system (cds0502 80306u283) insertion, air was noted in the gripper lever.Cds flushing was increased and the gripper lever cap was opened per ifu, flushing air out.After closing the cap, a leak was detected at the cap base.The gripper lever cap was re-fastened multiple times, however the leak remained.Reportedly, the caps were not loose.The cds was removed and another cds was used in replacement.Two mitraclips were implanted without reported issue, reducing the mr to grade 2.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported unstable gripper lever cap and gripper lever leak was confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and it appears that the reported leak appears to be related to the reported unstable lever cap which in turn is related to the observed protruding polyimide tubings over the o-ring as the polyimide protruding over the o-ring can prevent the cap from fully sealed to the lever and resulting in the observed leak at the lever.However, a definitive caused for how the polyimide protruded cannot be determined.It is possible that the polyimide tubing got unwrapped during troubleshooting of the inability to close the cap as the loose cap can resulted in the polyimide tubing to unwrap from its original position; however, this cannot be determined.Based on the information reviewed, 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: 7864780
• MDR Text Key: 119943487
• Report Number: 2024168-2018-07055
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80423U147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER