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

Catalog Number SGC01ST

Device Problem Physical Resistance (2578)

Patient Problems Perforation (2001); Respiratory Distress (2045)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported 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

This is filed to report that during use with the steerable guiding catheter, a suspected pulmonary vein perforation with bleeding into the lung occurred which required medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The fossa ovalis was tough and it took some time to pass the dilator and the steerable guiding catheter (sgc) through the atrial septum due to the resistance met.Two clips were implanted, reducing the mr to 2-3.A third clip delivery system (cds) was prepared for use, but before the cds was used, the patient's respiratory status deteriorated (spo2 decreased, blood visible in the endotracheal tube).The cardiologists and heart surgeon assumed a bleeding into the left lung via the pulmonary vein.The anesthesiologist could see some bleeding during bronchoscopy in the left lung.The procedure was aborted.The patient was stabilized with two thoratic drainages, bronchoscopic inspection/suction/application of norepiniphrine, double-lumen-tube, and catecholamines, and was then transferred to the icu.In the physicians' opinion, the bleeding was possibly caused by the guide wire during transseptal puncture and/or the sgc insertion into the left atrium, as the guide wire was positioned in the pulmonary vein.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 similar incidents reported from this lot.All available information was investigated and the reported physical resistance appears to be related to challenging patient anatomy.The reported perforation appears to be related to procedural conditions due to the guide wire transseptal puncture or the steerable guide catheter insertion into the left atrium, as the guide wire was positioned in the pulmonary vein; the reported respiratory distress was likely a cascading effect/symptom of the perforation.The additional therapy/non-surgical treatment, treatment with medications, and prolonged hospitalization were a result of case specific circumstances, as the patient was stabilized with two thoracic drainages, bronchoscopic inspection/suction/application of norepinephrine, double-lumen-tube, and catecholamines, and then transferred to the intensive care unit for recovery.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 5638161
• MDR Text Key: 44666101
• Report Number: 2024168-2016-02933
• 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,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60129U101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention