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

Model Number 2404-03

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a tip separation occurred.The 75% stenosed target lesion, with a relatively tight flexion sight, a length of 10mm to 15mm, was located in the moderately calcified proximal to mid left anterior descending artery (lad).It was noted that this was the area where the vessels were narrow and was the first vessel to be evaluated.Vascular access was obtained via the right radial artery.A non boston scientific company (bsc) 5fr diagnostic catheter was used during the procedure.A comet ii device was advanced to the lad and fractional flow reserve (ffr) was performed.It was noted that the comet device was not going to be used again in a different lesion.The procedure was completed and no patient complications occurred during the procedure.While outside the patient and during post procedure clean up, the comet ii was inserted into the hoop to dispose of, but it was noticed that a separation had occurred.The separation occurred 30 to 40 cm from the tip.It was noted that the separation had occurred without any resistance.It was additionally noted that no devices had been tracked over the comet ii device during the procedure, there was no observations of prolapse or kinks on the wire, the tip of the wire did not get trapped at any point during the procedure, and the tip of the non bsc diagnostic catheter had maintained position in the ostium during the entire procedure.No patient complications resulted in relation to this event.

Manufacturer Narrative

E1: initial reporter address: (b)(6).E1: initial reporter state: (b)(6).Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an ffr comet pressure wire in the shipping tube.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The wire was removed from the shipping tube.The wire showed that it was separated at 38cm from the tip.The wire shaft showed a kink located 42cm from the tip.The tip showed bend damage.With the wire returned separated signal verification could not take place.Upon connecting the device to the analysis support test bench equipment, it was noticed that the coefficient values were present.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Materials testing analysis and characterization identified that the seam weld exhibits signs of severe plastic deformation consistent with bend overload failure.Device analysis determined the condition of the returned device was consistent with the reported event of a separation.

Event Description

It was reported that a tip separation occurred.The 75% stenosed target lesion, with a relatively tight flexion sight, a length of 10mm to 15mm, was located in the moderately calcified proximal to mid left anterior descending artery (lad).It was noted that this was the area where the vessels were narrow and was the first vessel to be evaluated.Vascular access was obtained via the right radial artery.A non boston scientific company (bsc) 5fr diagnostic catheter was used during the procedure.A comet ii device was advanced to the lad and ffr was performed.It was noted that the comet device was not going to be used again in a different lesion.The procedure was completed and no patient complications occurred during the procedure.While outside the patient and during post procedure clean up, the comet ii was inserted into the hoop to dispose of, but it was noticed that a separation had occurred.The separation occurred 30 to 40 cm from the tip.It was noted that the separation had occurred without any resistance.It was additionally noted that no devices had been tracked over the comet ii device during the procedure, there was no observations of prolapse or kinks on the wire, the tip of the wire did not get trapped at any point during the procedure, and the tip of the non bsc diagnostic catheter had maintained position in the ostium during the entire procedure.No patient complications resulted in relation to this event.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10795601
• MDR Text Key: 215035382
• Report Number: 2134265-2020-15333
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: 08/28/2022
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0025933299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1