MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 2404-03

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device returned to manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of an ffr comet pressure wire in the shipping tube.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The wire showed that it was separated at 48cm from the tip.The wire shafts showed multiple small bends and kinks throughout the returned wires.With the wire returned separated signal verification could not take place.Upon connecting the device to the analysis support test bench equipment, it was noticed that the coefficient values were not present.This is an indication of the rfid tag not being programmed per document.With no coefficient values programmed the equipment would not recognize the device; therefore, no testing could be completed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported event of a separation.

Event Description

It was reported a device separation had occurred.During unpackaging of the comet pressure guidewire, it was noted that it was cut approximately 50cm from the tip.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10780111
• MDR Text Key: 214527557
• Report Number: 2134265-2020-15239
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0025933297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Date Device Manufactured: 08/28/2020
• 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