MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) WOVEN DIAGNOSTIC ELECTRODE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number H3017FMC006751

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.- the complaint device was received complete.The sample was visually inspected and no visible defect was found.Blood was observed in the connector.The electrodes area was submerged into a beaker full of water and it was injected with air using a syringe through the catheter.Bubbles appeared indicating a leak in the electrodes area.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based on analysis received on 08/14/2015.It was reported that there was blood between the connector and cable.The physician was performing paroxysmal supraventricular tachycardia (psvt) procedure in the coronary artery.A woven diagnostic electrode catheter was selected for use.During the procedure they founded blood in the cable connection between the catheter and the cable.The user reported there was no damage noted to the distal line of the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.Analysis of the returned device identified a leak in the electrode weld.

• Brand Name: WOVEN DIAGNOSTIC ELECTRODE 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): C R BARD INCORPORATED; 730 central avenue; murray hill NJ 07974
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5101362
• MDR Text Key: 26681169
• Report Number: 2134265-2015-06915
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: H3017FMC006751
• Device Catalogue Number: 7FMC00675
• Device Lot Number: GFYL1299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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
• Patient Age: 50 YR