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

Catalog Number SGC01ST

Device Problems Device Slipped (1584); Physical Resistance (2578)

Patient Problem Atrial Perforation (2511)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation; therefore, a failure analysis of the device could not be performed.The analysis of this complaint was an assessment of the information provided to abbott vascular, the manufacturing records and complaint history.The investigation determined that the reported slippage of the device and physical resistance appear to be related to user technique and patient anatomy.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported atrial perforation appears to be related to procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling.

Event Description

This event is being filed because the steerable guide catheter (sgc)slipped out of position and a shunt was noted, which required additional treatment to prevent permanent impairment to the patient.It was reported that the procedure on (b)(6) 2015 was to treat functional mitral regurgitation (mr) with a grade of 4.The first clip was deployed without issue, reducing mr to 1-2.During positioning of the second clip delivery system (cds), the stabilizer was moved to bring the cds closer to the deployed clip; however, after this maneuver, the steerable guide catheter (sgc) slipped from the left atrium to the right atrium.Attempts to reposition the sgc back into the left atrium were unsuccessful; therefore, the cds was retracted back into the sgg and the devices were removed together as a single unit.A shunt was then noted at the septum, which could not be treated as there was no appropriately sized treatment device available.The patient was transferred to the intensive care unit (icu) and the shunt was treated the following day.There was no reported adverse patient sequela and the patient was discharged from the hospital on (b)(6) 2015.There was no additional information 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: 5074489
• MDR Text Key: 25663042
• Report Number: 2024168-2015-05303
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 41126U209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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
• Treatment: OTHER: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention