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

Model Number	8900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the comet pressure guidewire fractured.The comet guidewire was selected for a procedure to treat the left anterior descending vessel.The wire fractured when trying to advance.There is no known harm to the patient.
Additional Manufacturer Narrative
The product was returned to boston scientific for analysis.Returned product consisted of separated guidewire.The device shaft was visually and microscopically inspected for damage.The device showed a small kink/bend located 166.5cm from the tip.The device showed a detached tip distal to the tip weld.The total wire (185cm) was not returned and accounted for.The returned device measured approximately 182cm long.There was approximately 3cm of the tip not returned.The wire was inserted into the pressure chamber test equipment and the pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.The coefficient was confirmed to be programmed.The occ handle was again connected to the ffr link.The device was then connected to the polaris (ilab) test equipment via bluetooth signal.The ffr link and wire communicated to the polaris system and zeroed as designed.With the wire inserted into the test pressure chamber, the wire transferred a pd pressure waveform to the polaris which indicates a functioning wire.The remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of tip detachment/fracture was confirmed.Device analysis determined the condition of the returned device was consistent with the reported information.
Event or Problem Description
It was reported that the comet pressure guidewire fractured.The comet guidewire was selected for a procedure to treat the left anterior descending vessel.The wire fractured when trying to advance.There is no known harm to the patient.

• 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: 10214585
• Report Number: 2134265-2020-08360
• Device Sequence Number: 2133925
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 0025000063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1