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

Model Number 8900

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

The comet guidewire was returned and analysis was completed.The occ cable was examined for any damage or irregularities.Visual examination of the occ cable showed that the rotating handle collet lock was completely separated from the housing.There were three kinks on the device located at 38 cm and 121.5 cm from the tip and also behind the occ handle.It was noticed that there was some slight peeling of the coating at the 121 cm location.The tip showed bend damage.The glue bond on the device was broken and the rotating cap was separated from the handle.The wire was removed from the cap/collet and it was noticed that the wire was kinked behind the cap.The complaint was confirmed for handle damage.The pressure wire was connected to the analysis support test bench and all applicable data was correct pertaining to coefficient values; however, the modulation values could not be confirmed due to the damage of the occ handle.

Event Description

Reportable based on analysis completed 17 july 2019.It was reported that the plug between the cable and wire portion of the comet pressure guidewire detached.There were no patient complications reported.However, device analysis revealed some slight peeling of the device coating.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8876065
• MDR Text Key: 153826337
• Report Number: 2134265-2019-09419
• 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: 08/08/2019

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: 04/09/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0023624586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1