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

Catalog Number SGC01ST

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported that during a mitraclip procedure, one clip was implanted.A second clip delivery system (cds) was introduced into the left atrium.In order to straddle the cds marker with the steerable guide catheter (sgc) markers, the sgc was pulled back approximately 5mm of the tip was left in the left atrium.The sgc was rotated posteriorly as the clip was close to the lateral wall.While rotating the sgc, it slid out of the left atrium into the right.As it was not certain if the clip remained in the left atrium, the clip was retracted into the sgc and removed from the anatomy.After removing the cds, the physician noticed the sgc hemostatic valve area had air in it.A syringe was connected and approximately 5cc of air was aspirated from the sgc and air bubbles were seen coming from the hemostatic valve.The physician felt as if there was a leak in the sgc and asked the device be replaced.No leak was detected during the instructions for use device preparation.Before the sgc was removed from the anatomy, a guide wire was introduced across the septum.Another sgc and cds were used for the procedure.Two clips were implanted reducing the degenerative mitral regurgitation grade from 4 to less than 1.Post procedure the patient was stable.There was no adverse patient effect or significant clinical delay in the procedure due to the device issue.No additional information was provided.

Event Description

Subsequent to the previously filed medwatch, additional information provided indicated that the physician did not inadvertently pull the sgc tip into the right atrium, but confirmed that as the sgc tip was close to the septum, it slid from the left atrium to the right when the sgc was being rotated.No additional information provided.

Manufacturer Narrative

(b)(4).Concomitant product: mitraclip system: clip delivery system, lift, support plate, stabilizer.The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the complaint device was returned and the reported leakage was not confirmed via returned product analysis.The reported slippage of device or component could not be replicated in a testing environment because it was based on operational circumstances.Analysis of the returned steerable guide catheter (sgc) found no damage was observed to the shaft.The sgc was tested for air and fluid leaks and the device passed all testing.The sgc functioned as intended; no leaks or slippage issues were identified.Potential causes for leaks are, but not limited to, user technique, manufacturing defects/anomalies (tears in the valve, missing silicone in the valve chamber), patient conditions (such as anatomical morphology/pathology, associated comorbidities, and disease state).In this case the device was inspected and was found to meet all manufacturing specifications.In manufacturing, all devices are subject to visually and functional inspection to verify product quality.Review of the device history record confirmed this device passed all in-process and final inspections, including verification that the sgc and all its components functioned as expected.There were no non-conformances issued for this lot that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no other similar leakage or slippage of device incidents reported for this lot.The user also reported no issue while functionally inspecting the sgc during device preparation, which is an indication that the device was functioning properly prior to use.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3561871
• MDR Text Key: 4062530
• Report Number: 2024168-2014-00140
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10262025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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