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 Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter location is not known.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed for arteriovenous fistula with bleeding.It was reported that on (b)(6) 2018, two mitraclips were implanted in a patient with mitral regurgitation (mr) 4+, reducing the mr to 3+.Reportedly, there was no device malfunction.Post-procedure, venous bloody oozing was noted, stopped by manual compression.There was no drop in hemoglobin.Angiography was performed and an arteriovenous fistula was noted, conservatively treated.No additional information was provided regarding this issue.

Manufacturer Narrative

(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 effects of hemorrhage and fistula, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported hemorrhage and fistula cannot be determined.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, 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
• 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: 8065094
• MDR Text Key: 126960502
• Report Number: 2024168-2018-08730
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

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: 06/22/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80621U358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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
• Treatment: 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 55