MAUDE Adverse Event Report: BOSTON SCIENTIFIC - LOWELL, MA CLEARSIGN? AMPLIFIER; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number H30120019680

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Same case as mdr 2134265-2015-00348.It was reported that unintended rf energy was delivered to the patient.During an ablation procedure, 10hz noise was seen on the ablation channel when no rf energy was applied.Somehow there was pacing captured in the atrium for the ablation catheter (10hz), indicating the ablation catheter was sending energy into the patient.No patient complications were reported and the patient is in good condition.No additional treatment was required.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the results of the testing indicated that the returned carto cable as well as the associated clearsign amplifier passed incoming inspection tests, including noise and leakage testing.The cable shielding connection was verified by measuring the capacitance and impedance and results were similar to the control cable.The possibility of interaction effects between the two components as a cause was eliminated by testing the returned complaint amplifier and cable together and found no issues.Both devices performed as expected.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

Same case as mdr 2134265-2015-00348.It was reported that unintended rf energy was delivered to the patient.During an ablation procedure, 10hz noise was seen on the ablation channel when no rf energy was applied.Somehow there was pacing captured in the atrium for the ablation catheter (10hz), indicating the ablation catheter was sending energy into the patient.No patient complications were reported and the patient is in good condition.No additional treatment was required.

• Brand Name: CLEARSIGN? AMPLIFIER
• Type of Device: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - LOWELL, MA; 55 technology drive; lowell MN 01851
• Manufacturer (Section G): BOSTON SCIENTIFIC - LOWELL, MA; 55 technology drive; lowell MN 01851
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4461056
• MDR Text Key: 22032022
• Report Number: 2134265-2015-00590
• Device Sequence Number: 1
• Product Code: DRQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2014

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 Model Number: H30120019680
• Device Catalogue Number: 2001968
• Device Lot Number: EPVI0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CLEARSIGN AMPLIFIER; SMART TOUCH CATHETER; STOCKERT GENERATOR, BIOSENSE WEBSTER