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

Catalog Number SGC0301

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

Patient Problems Thrombosis (2100); Tissue Damage (2104)

Event Date 02/20/2019

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 steerable guide catheter 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 thrombus/septal tissue during the procedure.It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).The steerable guide catheter (sgc) was advanced across the septum when thrombus was visualized on the dilator.The dilator was withdrawn into the sgc and the thrombus was aspirated.Additional information was received from the physician that what was originally thought to be thrombus may have been septal tissue upon crossing the septum.The sgc was removed and the device was flushed.Thrombus/septal tissue was flushed out in a bowl.A new sgc was used in the procedure.Two mitraclips were implanted reducing mr grade to trace.There was no adverse patient sequelae from the thrombus.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.The reported patient effects of thrombosis and mitral valve injury (tissue damage) are listed in the mitraclip system instructions for use, as known possible complications associated with mitraclip procedures.Review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A definitive cause for the reported patient effects could not be determined and may be related to case circumstances, as the physician stated that what was originally thought to be thrombus may have been septal tissue upon crossing the septum; however, this could not be confirmed.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: 8422509
• MDR Text Key: 138851381
• Report Number: 2024168-2019-02029
• 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: 03/29/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90108U103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention