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

Catalog Number SGC0302

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

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 additional relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) cable break.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was prepared for use with no issue; however, during introduction of the sgc, with minus on the guide, the sgc cable broke.It was not possible to apply plus or minus.The sgc was removed and replaced with a new one.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).All available information was investigated the reported mechanical issue of loss of tip deflection and cable break was confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the sgc cable break.The mechanical issue of loss of tip deflection however, was a secondary effect of the cable break.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: 7480319
• MDR Text Key: 107338911
• Report Number: 2024168-2018-03222
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80105U208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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