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

Catalog Number SGC0302

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report that the steerable guide catheter (sgc) could not be moved and the sgc leak.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with an mr grade of 4.The steerable guide catheter (sgc) was advanced, and the mitraclip delivery system was inserted.When positioning over the mitral valve, the sgc could not be moved and blood came out of the sgc handle.The sgc was removed and was replaced.There were no adverse patient effects.A total of two clips were implanted reducing mr to 1-2.The patient is stable.No additional information was provided.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported mechanical issue and leak was confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation determined that the screw on the handle adaptor was loose, which resulted in the mechanical issue and the leak.This issue appears to be related to a potential product quality issue.In conclusion, the results of the returned device analysis confirmed the mechanical issue and the leak.The cause of the mechanical issue and the leak was due to the identified loose screw on the handle adaptor.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 7520090
• MDR Text Key: 108622908
• Report Number: 2024168-2018-03659
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80213U251
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 88 YR