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

Catalog Number SGC01ST

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 07/21/2014

Event Type  Injury  

Event Description

This report is submitted for iliac vein perforation which occurred during use with the steerable guiding catheter and required medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 2-3.The transseptal puncture was performed without issue.The steerable guiding catheter was inserted into the groin approximately 10cm when the physician noted resistance.The initial resistance during advancement of the sgc was not unusual; however, once the resistance was noted, the physician stopped advancement.Under fluoroscopy it was confirmed that the tip was severely kinked.Angiography then confirmed a perforation of the iliac vein.The mitraclip system was removed and the bleeding was stopped with dilatation and two covered stents grafts.The procedure was aborted, and the patient required 1 pack of red blood cells.It was confirmed that the iliac vein was not calcified or tortuous, and there was no visible scar tissue.There was no difficulty accessing the femoral vein, and no difficulty noted with guide wire insertion.A clinically significant delay in the procedure was noted due to the perforation.The patient was extubated and was in good condition.There were no mitraclips implanted and the mr grade remained at 2-3.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional, relevant information.

Event Description

Subsequent to the initial report, additional information reported that the resistance during insertion of the steerable guiding catheter (sgc) was possibly due to a kink in the anatomy.

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records/complaint history and information provided to abbott vascular.Potential causes for the reported failure to advance the sgc shaft resulting in a kink can include, but are not limited to, patient conditions (such as anatomical morphology/pathology, associated comorbidities, and disease state), user technique/procedural conditions (procedural circumstances influencing the difficulty advancing the sgc) or manufacturing anomalies.A review of the device history record revealed no non-conformances that would have contributed to the reported event.Additionally, a review of the complaint history of the reported lot did not indicate a similar issue.The user also reported no issue while functionally inspecting the sgc during device prep, which is an indication that the device was functioning properly prior to use.With respect to patient condition, procedural conditions or user technique, the failure to advance the sgc resulting in a kinked shaft may be influenced by patient anatomy (tortuous anatomy, or physical obstruction), or user technique (sgc tip not straightened during advancement or the shaft not hydrated), preventing the sgc from advancing forward.In this case, it is possible that a kink in the anatomy caused difficulty advancing the sgc such that the shaft kinked upon advancement of the sgc into the kinked anatomy.Based on the information reviewed, the reported failure to advance the sgc and kink appear to be related to patient/procedural conditions.There is no indication of a product quality deficiency with respect to design, manufacturing, or labeling of the device.The reported perforation of the iliac vein was likely due to advancement of the sgc into the kinked anatomy.The perforation then led to the bleeding (hemorrhage).The reported perforation and hemorrhage appear to be related to patient/procedural conditions.The patient effects of perforation and hemorrhage as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product quality deficiency with respect to manufacture, design or labeling.

• 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: 4010617
• MDR Text Key: 17262422
• Report Number: 2024168-2014-05192
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10333215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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 Outcome(s): Required Intervention