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

Catalog Number SGC0301

Device Problems Device Slipped (1584); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The cds referenced is filed under a separate medwatch report.

Event Description

This is filed to report that the tip of the steerable guide catheter (sgc) became torn.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The sgc and the clip delivery system (cds) were in the left atrium when the sgc slipped back into the right atrium.The clip was brought back into the guide; however, during retraction the clip hit the soft tip of the sgc.When the sgc and cds were removed from the anatomy it was observed that the soft tip of the sgc was torn.New devices were prepped and used for the remainder of the procedure.1 clip was implanted and the final mr grade was 1.The patient was stable post-procedure.No adverse patient effects or a clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported steerable guide catheter (sgc) torn soft tip was confirmed.The reported slippage of the device could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).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 torn soft tip was a result of the clip getting caught on the guide tip; therefore, attributed to procedural conditions.The slippage of the device appears to be related to morphology/pathology due to the small atrium.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture 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: 6645700
• MDR Text Key: 77783760
• Report Number: 2024168-2017-05127
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2017
• Device Catalogue Number: SGC0301
• Device Lot Number: 61105U126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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: 86 YR
• Patient Weight: 62