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

Model Number 2404-03

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported foreign matter was present.When the comet ii pressure guidewire was taken out from the hoop during preparation, there was presence of a white-like object.The procedure was successfully completed with this device without further issue or patient injury.

Manufacturer Narrative

Device evaluated by mfr.: the returned product consisted of the ffr comet pressure wire with the occ cable.There was also a white twist tie (the reported white-like object) returned with the comet ii device.The occ cable, tip, device shaft, proximal face end, and sensor port were visually and microscopically examined for damage or any irregularities.There was no damage or irregularities to the device.The shroud of the occ cable was connected to the ffr link to verify the signal strength.There were no issues in connecting to the ffr link.The signal was present and the "signal strength" and the "zeroed" lights showed green, as designed.The shroud of the occ cable was then connected to the bench top testing equipment.The modulation was 15.6% and the coefficient values were confirmed to be programmed.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 shroud of the occ cable 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.With the wire inserted into the test pressure chamber, the wire transferred a pressure waveform to the polaris which indicates a functioning wire.The white twist tie that was returned with the device was then visually inspected.At which time, it was noticed to be the twist tie that is on the comet ii product in the manufacturing area.Operations quality engineering was then contacted and came to the analysis lab to further investigate the twist tie.It was determined by operations engineering that this white twist tie is the twist tie that the occ is wrapped with.It appeared that it was not thrown away when unwrapping the occ component and ended up being sealed in with the complaint device.Product analysis of the device and returned white-like object confirmed the reported event, as the white object was a white twist tie that is on the comet ii product in the manufacturing area.

Event Description

It was reported foreign matter was present.When the comet ii pressure guidewire was taken out from the hoop during preparation, there was presence of a white-like object.The procedure was successfully completed with this device without further issue or patient injury.

• 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: 14496880
• MDR Text Key: 292705500
• Report Number: 2134265-2022-05654
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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: 02/06/2024
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0028816032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2022
• 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