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

Catalog Number SGC01ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: (b)(4).The device was returned for evaluation.The returned device analysis found tears on the steerable guide catheter soft tip.The investigation concluded that the reported user experience and observed soft tip tear was related to procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.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 referenced is filed under a separate medwatch mfr number.

Event Description

This report is filed for the tear noted on the soft tip of the steerable guide catheter.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the left atrium.While steering down to the mitral valve, it was observed that the cds shaft was bent, and the device was diving medial and anterior.The cds was retracted back into the sgc.Resistance was noted between the clip and the tip of the sgc tip; therefore, the devices were removed together as a unit.The procedure was competed successfully using a new sgc and cds.One clip was implanted, reducing the mr to 1+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis found that the sgc soft tip was torn.

• 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: 5736647
• MDR Text Key: 47792347
• Report Number: 2024168-2016-04024
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112239
• 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: 06/20/2016

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: 09/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50930U144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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