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 Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the reported patient effect of vessel perforation appears to be related to procedural conditions and was likely caused by insertion of the steerable guide catheter(sgc).The reported hemorrhage appears to be a secondary effect of the perforation.The reported patient effects of vessel perforation or laceration and bleeding/hemorrhage, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the perforation.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 3-4.The steerable guide catheter (sgc) was inserted without issue, the clip delivery system (cds)was advanced successfully and one clip was implanted, reducing mr to <1.After the procedure, when the devices were removed, hemostasis of the femoral access failed.Contra femoral artery access was obtained and balloon angioplasty balloon was performed to treat the perforated right femoral artery.The artery was surgically closed.The procedure was prolonged two hours due to the arteriotomy.It is the physicians opinion that the perforation was caused by the sgc.The patient is stable.No additional information was provided.

• 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: 7033658
• MDR Text Key: 92089068
• Report Number: 2024168-2017-08985
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70814U245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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: IMPLANTED MITRACLIP (X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 52