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

Catalog Number SGC01ST

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

This is being filed as air was seen within the steerable guide catheter (sgc 40616u1/20).Although there was no adverse patient effect, air has the potential to cause or contribute to patient injury.It was reported that the mitraclip sgc (40616u1/19) was prepared for use as per the instructions for use (ifu).No air bubbles were noted during device preparation.After the sgc was placed in the left atrium, the dilator and guide wire were retracted into the sgc.The echocardiogram image showed the tip of the sgc was in the center of the left atrium.As the dilator and guide wire were started to be retracted as one unit, the sgc was aspirated.After a few seconds of aspirating and 15cm of the dilator/guide wire remained in the sgc, air bubbles started appearing and filling the hemostatic valve, syringe and in the proximal part of the catheter.The stopcock, tubing and syringe connections were confirmed to be "fine".The sgc with dilator/guide wire was removed from the anatomy.Another sgc (40616u1/20) was prepared for use.During retraction of the dilator/guide wire, air bubbles were seen again when approximately 15cm dilator/guide wire remained in the sgc.The air bubbles were managed until the dilator/guide wire were fully retracted and once removed from the sgc, aspiration was continued until the sgc hemostatic valve was fully filled with blood without any air entering.The procedure was continued.The clip was implanted reducing the functional mitral regurgitation grade from 4 to 1-2.There was no adverse patient effect due to the air in the device.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The other steerable guide catheter device (40616u1/19) referenced, is being filed under a separate medwatch mfr number.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported leak in the steerable guiding catheter (sgc) could not be confirmed via returned device analysis.With respect to user technique/procedural conditions, sgc leaks can be influenced by the steps utilized at the account during device preparation, such as not fully de-airing the sgc shaft during device preparation or loose connections between the luer and accessory devices (i.E.Stopcock, high pressure tubing or syringe).It is possible that there were some residual air bubbles in the sgc device / dilator which appeared in the sgc hemostasis valve during dilator retraction; however, this cannot be confirmed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.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: 4487770
• MDR Text Key: 5500642
• Report Number: 2024168-2015-00616
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 40616U1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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: MITRACLIP SYSTEM
• Patient Weight: 75