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

Model Number 8900

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  malfunction  

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 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
• 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: 10734802
• MDR Text Key: 213053583
• Report Number: 2134265-2020-14503
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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