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

Catalog Number SGC0301

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The clip delivery system referenced is filed under a separate medwatch report.

Event Description

This is filed to report a tear in the soft tip of the steerable guide catheter (sgc).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Advancement of the clip delivery system (cds) was performed without issue.The patient weighed (b)(6) making the visibility of the clip more challenging.Due to the flailing and severely prolapsed posterior leaflet attempts to grasp and maintain capture of the leaflets failed.The cds was retracted, but got caught on the soft tip of the sgc.The clip was opened slightly and moved away from the tip of the guide and reclosed and retracted again without any further issue.After removal of the sgc, the soft tip was observed to be torn, but still intact.The final mr grade was 4.No further treatment was performed.No adverse patient effect or clinically significant delay in the procedure was reported.No additional information was provided.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported torn soft tip was confirmed.The reported difficulty removing the clip delivery system/cds (clip caught on soft tip) was not confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported clip getting caught on the guide tip, resulting in the tear in the soft tip appears to be related to user technique due to slight rotation of the clip while retracting the cds.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: 7466209
• MDR Text Key: 106843285
• Report Number: 2024168-2018-03111
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 71028U141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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 Age: 69 YR
• Patient Weight: 181