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

Catalog Number SGC0302

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

Patient Problem Perforation (2001)

Event Date 05/30/2019

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 for perforation of the right iliac vein requiring percutaneous repair.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.During insertion of the steerable guide catheter (sgc), resistance was noted while advancing the catheter through the femoral vein.It was observed on fluoroscopy that the loop of the guidewire was causing the sgc to be kinked in the right iliac vein.Upon sgc removal, damage to the right iliac vein was observed on fluoroscopy; a leak was seen.The patient was stable and the lesion was successfully repaired percutaneously with covered stents.The mitraclip procedure was aborted.Post procedure mr remained at grade 4.On (b)(6) 2019, a mitraclip was successfully implanted reducing mr from 4 to 1.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.Additionally, a review of the complaint history no similar incidents reported from this lot.The reported difficulty inserting the sgc appears to be related to the kink in the sgc and the kink was due to the loop of the guidewire (procedural conditions).The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The perforation was due to procedural conditions.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: 8714553
• MDR Text Key: 148526364
• Report Number: 2024168-2019-04885
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90311U131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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