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 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of a 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 61.5cm 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 wire functioned as designed.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink and the peeling of the coating were attributable to handling of the device.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on device analysis completed on 10nov2017.It was reported that a comet wire was not used due to ffr link malfunction.During the preparation outside the patient, a comet pressure guidewire was opened to perform fractionated flow reserve (ffr) measurement.Then it was noticed that the ffr link would not switch on.Different plug points and power cables were tried but would not work.The procedure was not completed due to this event.No patient complications were reported and the patient¿s status was stable.However, the returned device revealed 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: 7083605
• MDR Text Key: 94503905
• Report Number: 2134265-2017-11613
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: ZA
• 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: 11/10/2017

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: 12/31/2017
• Device Model Number: H7493932430
• Device Lot Number: 20456775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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