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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

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 relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) air leak.It was reported this was a mitraclip procedure to treat grade 4 mixed mitral regurgitation (mr).The sgc was inserted in the left atrium.When the clip introducer was inserted in the hemostatic valve of the sgc, air entered the sgc.The clip introducer was removed, and air continued to enter through the sgc valve.A second attempt was made to insert the clip introducer into the sgc, but air continued to enter the sgc.A new sgc was used with the same cds and clip introducer without issue.A total of two clips were implanted, reducing mr to 1.There was no reported adverse patient effect or a clinically significant delay during the procedure.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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported air (leak) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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 4628
• MDR Report Key: 8200637
• MDR Text Key: 131536676
• Report Number: 2024168-2018-10056
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81101U216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP INTRODUCER; CLIP INTRODUCER
• Patient Age: 80 YR
• Patient Weight: 65