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

Catalog Number SGC0302

Device Problem Difficult to Insert (1316)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 on the steerable guide catheter to report the vessel bleed which required surgical intervention.It was reported that on (b)(6) 2018 this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (fmr).After the transeptal puncture, the physician tried to insert the steerable guide catheter (sgc) according to the instructions for use (ifu), but resistance was met after the sgc was inserted a few centimeters into the right femoral vein.During sgc insertion, the physician observed heavy bleeding from the right femoral vein.There was no calcium, tortuosity, or other challenging anatomy observed at the femoral vein.Zero mitraclips were implanted and mr grade was unchanged at grade 4.The procedure was aborted and the sgc was removed.There was no damage noted on the sgc.Surgical repair of the femoral vein was performed using surgical sutures.During the repair, the patient received one unit of a blood transfusion.Another mitraclip procedure was performed successfully on (b)(6) 2018 reducing mr grade to 2 with two mitraclips.The patient is in stable condition.No additional information was provided.

Manufacturer Narrative

(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.Review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported difficult to insert the steerable guide catheter (sgc) cannot be determined.It is possible that there were procedural interactions (e.G.Patient anatomy in conjunction with unintended/excessive curves on the device) which resulted in increased tension on the device and therefore contributed to the reported adverse event; however, this cannot be definitively confirmed.The reported hemorrhage appears to be related to procedural circumstances as resistance was met while advancing the sgc and bleeding from the right femoral vein was noted.The reported patient effect of hemorrhage, as listed in the mitraclip system instructions for use, is a known possible complication 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8166785
• MDR Text Key: 130457849
• Report Number: 2024168-2018-09729
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80815U151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68