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

Catalog Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem Bradycardia (1751)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 leak and treatment with aspiration and medication.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the left atrium.The dilator was removed for aspiration and air was observed in the syringe.It was confirmed that the sgc was not against any structures of the heart.Aspiration was performed and the air was removed.The clip delivery system (cds) was advanced to the mitral valve.While grasping, the patients heart rate suddenly dropped to 13 beats per minute (bpm).Atropine was administered and the patient was stabilized.The clip was deployed without issue, reducing mr to 1-2.There was no clinically significant delay in 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.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 in leak in this incident could not be determined.The definitive cause for bradycardia could not be confirmed.The reported patient effect of bradycardia is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.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: 8117192
• MDR Text Key: 128860909
• Report Number: 2024168-2018-09149
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 80730U135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 118