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

Catalog Number SGC0302

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The sgc was noted to have a torn soft tip.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the observed tear in the soft tip may be related to an issue related to procedural conditions (the open clip was pulled into the sgc) or post-procedural shipping and handling.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system has been filed under mfr report # 2024168-2017-07639.

Event Description

This is filed to report the soft tip tear.It was reported that the patient, with grade 3 functional mitral regurgitation (mr), underwent a mitraclip procedure.The clip delivery system (cds) was advanced into the patient anatomy, but during removal, could not be fully closed, so it was removed from the anatomy (see mfr report # 2024168-2017-07639) with the steerable guide catheter (sgc) as a single unit.There were no reported issues with the sgc; however, the device was returned and a soft tip tear was noted.No additional information was provided.

• 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: 6908205
• MDR Text Key: 88113948
• Report Number: 2024168-2017-07903
• 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
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70419U213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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: 63 YR
• Patient Weight: 82