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

Catalog Number SGC0302

Device Problem Difficult to Insert (1316)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 04/16/2019

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 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 vessel laceration requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During insertion of the steerable guide catheter (sgc), resistance was noted and the guide wire was noted to be kinked.The guide wire was retracted and the sgc was re-advanced.The patient became hemodynamically unstable and the blood pressure dropped.The procedure was discontinued and the femoral access was checked.A laceration was found at the right femoral access.A covered stent was implanted for treatment and the blood pressure returned to normal.No clips were implanted and the mr remained at 4.The cause of the laceration could not be confirmed.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: expiration date changed from 01/30/2019 to 01/30/2020.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported for difficult to remove the sgc from this lot.All available information was investigated, and a definitive cause for the reported difficult to insert the sgc into the patient anatomy could not be determined in this incident.The reported perforation appears to be due to operational context (procedural circumstances) and the reported hypotension appears to be the cascading effect of the observed perforation.The reported adverse event/patient effect of hypotension and perforation as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 8587251
• MDR Text Key: 144298346
• Report Number: 2024168-2019-03600
• 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,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90130U159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention