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

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/10/2018

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 conservatively filed as thrombus was noted during device use.It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 4+.The steerable guide catheter was advanced to the right atrium (ra) when thrombosis was noted in the ra.The operators decided to continue with the procedure.There was no thrombus in the left atrium and per physician, the thrombosis was believed to have been due to an unspecified guide wire.There was no reported treatment.One mitraclip was implanted at the a2/p2 region, reducing the mr to 1+.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc).The reported patient effect of thrombosis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on information reviewed, the reported thrombus appears to be related to the guide wire; therefore, attributed to procedural conditions.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: 8021956
• MDR Text Key: 125592983
• Report Number: 2024168-2018-08301
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80612U118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 35