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

Model Number	8900
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an ffr comet pressure wire connected to the occ cable.The wire returned separated from the customer site.Both pieces were returned.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed multiple kinks and bends on the returned components.The device was kinked and separated when it was received from the customer site located 64.5cm from the tip.The tip showed bend damage.The device could not be tested for signal verification due to the damage on the device when returned.The coefficient values were confirmed to be programmed.The wire was removed from the occ handle with no issues.The sensor port showed no residue of body fluids.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for removing the wire from the occ handle cap and collet.
Event or Problem Description
It was reported that failure to disconnect a wire occurred.A comet pressure guidewire was used during in a percutaneous coronary intervention (pci) for measurement of the target lesion.However, after measurement, the wire was unable to disconnect from the comet device.The device was removed and the procedure was completed with a different device.No patient complications were reported in relation to this event.However, the device returned and analysis revealed that the pressure guidewire was detached/separated at the mid section.

• 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: 10734802
• Report Number: 2134265-2020-14503
• Device Sequence Number: 11044723
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 03/16/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025362297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1