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

Model Number	8900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Chest Pain (1776); ST Segment Elevation (2059)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned product consisted of an ffr comet pressure wire connected to the occ handle.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The devices shaft showed one kink located 126.5cm from the tip.The tip showed a bend.The occ handle was connected to the ffr link to verify the signal strength.The signal was present as designed.The sensor port showed no residue of body fluids.The occ handle was then connected to the bench top testing equipment and the wire was inserted into the pressure chamber.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 in specification.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 wire communicated to the polaris system and zeroed as designed.The wire was inserted into the test pressure chamber and the wire transferred a pressure waveform to the polaris which indicated a functioning wire.The wire was removed from the occ handle with no issues.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink and tip damage were attributable to handling issues.
Event or Problem Description
It was reported that chest pain and st segment changes occurred.A percutaneous coronary intervention was being performed on a previously known left anterior descending stent and 100% occluded circumflex artery.An angiogram of the right coronary artery showed an intermediate mid lesion and dfr was performed to determine significance.After equalization, the dfr value distal to the lesion read 0.81.The comet wire was disconnected and a 3.0x24mm drug eluding stent was directly implanted over the comet wire to the lesion.A slightly hazy region was noted distal to the stent and another 3.0x8mm drug eluding stent was implanted on the distal overlap of the first stent to cover the hazy region.The patient started to experience some chest pain and st segment changes at this point.The comet wire was reconnected and another dfr measurement was made resulting in 0.80.No further intervention was performed and the patient was stabilized and no longer complaining of chest pain when he left the room.

• 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: 9672855
• Report Number: 2134265-2020-00869
• Device Sequence Number: 2913492
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024835791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR