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

Catalog Number SGC0302

Device Problem Unintended Movement (3026)

Patient Problems Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 12/13/2018

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 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 that the steerable guide catheter (sgc) jumped into the left atrium resulting in fossa rupture.A it was reported that this was a mitraclip procedure to treat a functional mitral regurgitation (mr) with a grade of 4.During advancement of the sgc, the sgc jumped into the left atrium causing a rupture in the fossa.This resulted in a shunt in both directions and a drop in oxygen from 100% to 94% which was controlled by applying 100% oxygen.The procedure was aborted and the patient was transferred to conventional heart surgery for treatment of the fossa rupture and mr.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 slippage of device or device component cannot be determined in this incident.The reported atrial septal defect (asd) likely occurred due to device slippage.The respiratory distress was due to the atrial septal defect (asd).The reported patient effects of asd and respiratory distress are listed in the mitraclip system instructions for use as 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: 8217493
• MDR Text Key: 132081190
• Report Number: 2024168-2019-00063
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80824U211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability