MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE BLAZER¿ OPEN-IRRIGATED; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M004EPT96200

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

Patient Problem Thrombosis (2100)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id 2134265-2016-07324.It was reported that clotting occurred.The lesion being treated was located in the right ventricle outflow tract (rvot) with 50% premature ventricular contraction (pvc).An intellamap orion catheter was selected for a 3d mapping case.During advancement the catheter was found to be too stiff to go around the rvot, requiring a sheath driven by the blazer open-irrigated catheter.Ablation catheter to the pulmonary valve.During the case, the orion catheter kept falling back in the right ventricle (rv), requiring repeat maneuvers.Throughout the case clot was forming in the basket of the orion requiring forceps for removal.No heparin was administered; however it was noted that irrigation was performed throughout the procedure.The orion and ablation catheter did not sit well in the confined space of the rvot.The orion was closed and brought back in to the right atrium (ra), however this caused the geometry to become inaccurate and remapping was needed.The foci was identified based on conventional mapping and a single ablation stopped pvcs.Blazer open-irrigated catheter.No further patient complications were reported and the patient's status is stable.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that no heparin was given and medication to maintain act was not provided.

• Brand Name: BLAZER¿ OPEN-IRRIGATED
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5882165
• MDR Text Key: 52300062
• Report Number: 2134265-2016-07594
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M004EPT96200
• Device Catalogue Number: EPT9620
• Device Lot Number: 17863102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2015
• 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