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

Model Number	8900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at wire break occurred.This comet pressure guidewire was selected.During the procedure the unspecified guide catheter became kinked and they were unable to torque the wire.While removing the device the guidewire broke.The guide catheter and guidewire were both removed from the patient.There was no harm report to the patient.
Event or Problem Description
It was reported that at wire break occurred.This comet pressure guidewire was selected.During the procedure the unspecified guide catheter became kinked and they were unable to torque the wire.While removing the device the guidewire broke.The guide catheter and guidewire were both removed from the patient.There was no harm report to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: the devices shaft was visually and microscopically inspected for damage.The device showed a separation located 27cm from the tip.The total wire (185cm) was returned and accounted for.Functionality of the device could not be confirmed due to the damage of the device.The coefficient was confirmed to be programmed per specifications.The device showed a kink at the occ handle as well as peeled coating at this location and there were signs of body fluids in the sensor housing.Scanning electron microscopy testing identified that the fracture occurred in the slotted tube region at the beam connection.The slotted tube was bent at the location of the fracture.Distal and proximal fractured surfaces show microviod coalescence which are indicative of ductile overload.There were no narrow beam widths.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: COMET
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9930605
• Report Number: 2134265-2020-04208
• Device Sequence Number: 701603
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025003198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/21/2020
• Patient Sequence Number: 1