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

Model Number	8900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip separation, unretrieved device fragment, additional intervention, and vascular perforation occurred.A coronarography was performed on a lesion in the intermediate stenosed right coronary artery (rca).Vascular access was obtained via the radial artery.A comet wire was advanced, and while navigating into the 2nd segment of the rca, the radiopaque segment fractured, which remained in the vessel.It was noted that while progressing in the rca to reach the lesion intended for evaluation, the radiopaque segment of the comet wire was observed to be fractured and separated from the wire.The separation occurred 3cm from the tip.A new angiography was performed and there was an attempt to withdraw the fractured segment during the second procedure but failed and resulted with a vascular perforation.It was noted that the tip of the guide/diagnostic catheter maintained position in the ostium during the entire procedure.It was later reported that no other devices were tracked over the wire and that the comet wire fractured when navigating down the artery, there was no abnormality in the patient's anatomy, and the tip did not become trapped at any point during the procedure.The procedure was not completed successfully.No additional patient complications were reported in relation to this event.
Event or Problem Description
It was reported that tip separation, unretrieved device fragment, additional intervention, and vascular perforation occurred.A coronarography was performed on a lesion in the intermediate stenosed right coronary artery (rca).Vascular access was obtained via the radial artery.A comet wire was advanced, and while navigating into the 2nd segment of the rca, the radiopaque segment fractured, which remained in the vessel.It was noted that while progressing in the rca to reach the lesion intended for evaluation, the radiopaque segment of the comet wire was observed to be fractured and separated from the wire.The separation occurred 3cm from the tip.A new angiography was performed and there was an attempt to withdraw the fractured segment during the second procedure but failed and resulted with a vascular perforation.It was noted that the tip of the guide/diagnostic catheter maintained position in the ostium during the entire procedure.It was later reported that no other devices were tracked over the wire and that the comet wire fractured when navigating down the artery, there was no abnormality in in the patient's anatomy, and the tip did not become trapped at any point during the procedure.The procedure was not completed successfully.No additional patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device returned to manufacturer: the devices shaft was visually and microscopically inspected for damage.The device showed multiple kinks and bends throughout the wire shaft.The tip was separated from the shaft at 3cm.The separation was not on the laser cut part of the shaft.The coefficient was confirmed to be programmed per specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of device tip detachment was confirmed.Device analysis determined the condition of the returned device was consistent with the reported information.

• 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: 11050862
• Report Number: 2134265-2020-18196
• Device Sequence Number: 2652112
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0026348591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention