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

Model Number H7493932430

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a fractionated flow reserve (ffr) comet pressure wire.The tip, device shaft, sensor port and the coefficient values was examined for damage or any irregularities.The shaft showed a kink.The kink was approximately 89cm from the tip.There was also some slight peeling of the coating on the kinked area.The tip showed no damage.The sensor port was clear of any material.Inspection of the remainder of the device revealed no other damage or irregularities.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.The coefficient was confirmed to be in specification.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that the comet wire was not detected.During preparation, a comet pressure guidewire was selected to perform fractionated flow reserve (ffr) measurement, however, it could not be detected by the polaris imaging system.The device was removed and the procedure was completed with a different device.No patient complications were reported.However, the returned device revealed teflon coating peeled off.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6987519
• MDR Text Key: 91079453
• Report Number: 2134265-2017-10948
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2017

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 Expiration Date: 01/30/2018
• Device Model Number: H7493932430
• Device Lot Number: 20606687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2017
• 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