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

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the atrial perforation.It was reported that on (b)(6) 2018, the patient with functional mitral regurgitation (mr), underwent a mitraclip procedure.The steerable guide catheter (sgc) was advanced into the patient anatomy.The clip delivery system (cds) was advanced and during clip placement, it was noted that the oxygen saturation had dropped to 70%.An atrial septum rupture occurred, resulting in right to left shunt.The clip was implanted, successfully reducing mr from grade 4 to grade 2-3.It was decided to end the procedure because the oxygen saturation decreased to below 60%.An amplatzer atrial septal defect (asd) occluder was implanted to repair the atrial septum and the oxygen saturation increased to normal values.The patient was in stable condition post procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of atrial septal defect requiring intervention and respiratory failure, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported atrial perforation could not be determined; however, the reported respiratory distress appears to be due to the atrial perforation.Although a conclusive cause for the reported patient effect of atrial perforation and the relationship to the device, if any, could not be determined, there is no indication of a product quality issue 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 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: 7445344
• MDR Text Key: 106001909
• Report Number: 2024168-2018-02918
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 71222U136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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): Required Intervention