MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

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

Patient Problem Thrombosis (2100)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a ffr comet pressure wire in one piece.Visual inspection of the device revealed no damage or irregularities.Visual examination of the sensor port showed that the port did have some residual thrombus present.With the residual thrombus inside of the sensor port, this could potentially block the sensor from gathering a signal during the procedure and show an equalizing error like the one the customer witnessed.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire.There was no evidence of any damage or irregularities contributing to the reported equalizing issues.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 24may2016 that revealed residual thrombus inside of the sensor port.It was reported that the device was unable to equalize.The lesion was located in the right coronary artery (rca).After insertion of comet fractional flow reserve (ffr) wire into guide catheter, the staff was unable to equalize pressures despite multiple attempts to do so.A 2nd wire was opened and equalized without difficulty.There were no complications to the patient.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5743599
• MDR Text Key: 47994801
• Report Number: 2134265-2016-06136
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: H7495551110
• Device Lot Number: 19062362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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): Other