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

Catalog Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problems Thrombosis (2100); Visual Disturbances (2140)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is being filed to report the steerable guide catheter (sgc) leak and thrombus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade of 4+.During preparation of the steerable guiding catheter (sgc), while functional testing was performed air bubbles were observed in the hemostatic valve.The sgc was re-tested with no issues, no more air bubbles were noted; therefore, the sgc was advanced into the patients anatomy.When advancing from the right atrium to left atrium thrombus was noted on the guide.The thrombus was aspirated.Although, there was no more issue with the sgc, but because of the thrombus, the physician decided to remove the sgc.A new sgc was prepped and used without issue.One clip was implanted reducing mr to 1+.The patient experienced double vision post procedure.Anticoagulation was given during hospital stay prior to discharge.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 other incidents reported from this lot.The reported patient effect of thrombus, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported leak and patient effect of thrombus and vision disturbance could not be determined.Additionally, the reported therapy/non-surgical treatment and treatment with medication were a result of case specific circumstances.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: 8718290
• MDR Text Key: 148655329
• Report Number: 2024168-2019-04912
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90402U206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR