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

Catalog Number SGC0301

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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 to report the perforation.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) began to be advanced, but resistance was felt in the groin.X-ray was performed and it was observed that the tip of the sgc was folding over.The sgc was slightly retracted to straighten the device.The sgc was then advanced further, but resistance was met again.Angiography was performed, which found that the inferior vena cava (ivc) was very tortuous and a perforation had occurred.The sgc was removed and the procedure was discontinued.The patient remained hospitalized for monitoring and no further treatment has been planned.No additional information was provided.

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of vessel perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported failure to advance the steerable guide catheter (sgc) appears to be related to patient morphology/pathology.The sgc tip folding over was likely a secondary effect of the failure to advance, as attempting to advance the sgc forward likely placed increased tension on the distal end of the sgc shaft.The reported patient effect of perforation was likely a result of procedural conditions, and due to attempts to advance the sgc forward through the tortuous anatomy.Based on the information reviewed, 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: 7291168
• MDR Text Key: 100759587
• Report Number: 2024168-2018-01345
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70516U103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 54