MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) BLAZER? DX-20 CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M00420SL21020

Device Problem Difficult To Position (1467)

Patient Problem Atrial Perforation (2511)

Event Date 12/12/2014

Event Type  Injury  

Event Description

It was reported that a perforation occurred.The target lesion was located in the tortuous right atrium.A 7f/sup lg/2-10-2mm blazer¿ dx-20 catheter was selected for diagnosis.During procedure, the physician manipulated the catheter in the right atrium and observed problems in moving the catheter due to the tortuous anatomy.The physician ordered for an echocardiogram and noted that the lateral wall of the right atrium was perforated.The physician performed pericardiocentesis and aborted the case.No further patient complications were reported and the patient's condition was stable.

Manufacturer Narrative

(b)(4).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).

• Brand Name: BLAZER? DX-20 CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• 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: 4394503
• MDR Text Key: 22031983
• Report Number: 2134265-2014-08198
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00420SL21020
• Device Catalogue Number: 20SL2102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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