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

Model Number 8900

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer: the comet was returned without the handle and analysis was completed.The tip, device shaft and sensor port were examined for damage or any irregularities.The investigation of the shaft of the device showed no damage.The tip showed a bend.It was noticed that there was some peeling of the coating located 81cm from the tip and continued along the shaft to 131cm.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 peeled coating and the tip damage was attributable to handling issues; therefore, the conclusion code unintended use error caused or contributed to event.

Event Description

It was reported that foreign matter was noted after a procedure.A procedure had been completed with the use of a comet pressure guidewire.Upon removing the comet from the y adaptor, it was wiped with a saline gauze material.It was noticed that a lot of black sediment was on the gauze thereafter.No injury was encountered by the patient.

• 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: 9559325
• MDR Text Key: 177631766
• Report Number: 2134265-2019-15879
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2020

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: 07/11/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024100281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• 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