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

Catalog Number SGC0301

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This report is filed for retroperitoneal bleeding post procedure.It was reported that this was a mitraclip procedure treating mitral regurgitation (mr) grade 4.The steerable guide catheter (sgc) was advanced and resistance was possibly met.The device was used without further issue and three mitraclips were implanted, reducing the mr to grade 1.The femoral vein was closed as per standard procedure protocol with an arteriotomy closure device.Post-procedure, a retroperitoneal bleed (rpb) was noted from the iliac vein.Per physician, the rpb was possibly due to the steerable guide catheter.A vascular surgeon first attempted to treat the bleeding with a balloon and then performed vascular surgical repair.The event resolved and the patient has been discharged.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that the reported patient effects of vessel perforation and hemorrhage, as listed in the mitraclip system instructions for use (ifu) is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported physical resistance during steerable guide catheter (sgc)advancement appears to be due to the procedural conditions/user technique.Additionally, the reported perforation appears to be the cascading/procedural condition of physical resistance with anatomy.However, the reported hemorrhage appears to be the secondary effect of the reported perforation.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: 7891494
• MDR Text Key: 120821510
• Report Number: 2024168-2018-07283
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80215U137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 80