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

Catalog Number SGC0101

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

Patient Problem Atrial Perforation (2511)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(5).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the steerable guiding catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is conservatively filed to report that after the steerable guiding catheter (sgc) was advanced into the anatomy, a pericardial effusion was observed.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.After the steerable guiding catheter (sgc) was advanced into the left atrium, a pericardial effusion was observed.In the physicians opinion, the effusion was possibly caused while trying to find a good position on the septum with the transseptal sheath, prior to insertion of the sgc.A drainage tube was inserted into the pericardium and aspiration was performed.The patient remained stable.After drainage, the effusion seemed decreased and the procedure was continued with optimal clinical outcome.Two clips were implanted, reducing the mr to 1+.It was noted that during the procedure, blood was given to the patient.The patient is currently stable.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 pericardial effusion and atrial perforation, as listed in the mitraclip system instructions for use, are listed as known possible complications associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported patient effect of pericardial effusion and atrial perforation could not be determined.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot 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: 6049477
• MDR Text Key: 58130839
• Report Number: 2024168-2016-07221
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K161985
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60602U136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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
• Treatment: MITRACLIP SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 69