MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) CLEARSIGN¿ AMPLIFIER; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number M00420012530

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

Same case as mfr id # 2134265-2017-12128.It was reported that incorrect pacing occurred.It was reported that during an electrophysiology procedure involving an lspro and a non-bsc simulator, pacing was delivered to the atrium; however, pacing was also delivered to the ventricle though a secondary catheter located in the ventricle.The physician was only able to resolve the secondary pacing by physically unplugging the catheter that was located in the ventricle in order to only pace the atrium.It was suspected that the cable may have been internally damaged; however no visual damage was observed.No patient complications reported.

• Brand Name: CLEARSIGN¿ AMPLIFIER
• Type of Device: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7117284
• MDR Text Key: 94951947
• Report Number: 2134265-2017-12133
• Device Sequence Number: 1
• Product Code: DRQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2017

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: M00420012530
• Device Catalogue Number: 2001253
• Device Lot Number: 1906212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2017
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1