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

Model Number 8900

Device Problems Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 11/18/2019

Event Type  Injury  

Event Description

It was reported that a wire detachment occurred.Vascular access was obtained via the right radial artery using a non-bsc 4fr angiographic catheter.Imaging was performed in the left coronary artery using a non-bsc 4f dual-use catheter.After this comet pressure guidewire was selected to evaluate the ischemia in the 50%-75% stenosed, moderately calcified right coronary artery (rca).There was no complex tortuosity in the rca and the guide catheter placement was stable.The comet wire entered the right marginal artery (rv branch) once or twice and was slightly pulled back before reaching the lesion.The comet wire was in the rv main vessel when they tried to advance the comet wire again; however, the pd signal disappeared.The comet wire was manipulated, but was not responding.Visualization was performed via x-ray, the tip detached and remained in the vessel.The comet wire separated approximately 32mm from the distal tip and 2mm from the sensor.The guide catheter was replaced immediately and the comet wire tip was retrieved using a non bsc 6fr guide catheter and a gooseneck snare.It was noted that the comet wire became kinked during removal not during the procedure.Throughout the procedure, guiding/diagnostic catheter tip part was being held in the entry port position.The comet wire did not prolapse or become stuck during the case.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

The returned product consisted of a ffr comet pressure wire.The separated distal end and the occ cable was not returned.The devices shaft was visually and microscopically inspected for damage.The device showed a separation located approximately 3.2cm from the tip.The proximal shaft was returned and measured 181.8cm in length.The 2 components that were returned equaled 185cm in length which is the length of a complete comet wire.The tip looked to have a kink.The separated end looks to have been caused by a bending force break.The proximal end looked to have a very slight bend under magnification.The pressure wire could not be connected to the analysis support test bench due to the damage of the wire; therefore, the pressure issues that were stated by the customer could not be confirmed.A scanning electron microscopy analysis revealed that the unit cracks at the slotted tube region at the beam locations.Some striations on both beams appear to suggest that the failure likely occurred due to reverse bending fatigue, with possible final ductile overload.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of detachment of the device was confirmed.

Event Description

It was reported that a wire detachment occurred.Vascular access was obtained via the right radial artery using a nonbsc 4fr angiographic catheter.Imaging was performed in the left coronary artery using a non-bsc 4f dual-use catheter.After this comet pressure guidewire was selected to evaluate the ischemia in the 50%-75% stenosed, moderately calcified right coronary artery (rca).There was no complex tortuosity in the rca and the guide catheter placement was stable.The comet wire entered the right marginal artery (rv branch) once or twice and was slightly pulled back before reaching the lesion.The comet wire was in the rv main vessel when they tried to advance the comet wire again; however, the pd signal disappeared.The comet wire was manipulated, but was not responding.Visualization was performed via x-ray, the tip detached and remained in the vessel.The comet wire separated approximately 32mm from the distal tip and 2mm from the sensor.The guide catheter was replaced immediately and the comet wire tip was retrieved using a non bsc 6fr guide catheter and a gooseneck snare.It was noted that the comet wire became kinked during removal not during the procedure.Throughout the procedure, guiding/diagnostic catheter tip part was being held in the entry port position.The comet wire did not prolapse or become stuck during the case.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9440582
• MDR Text Key: 170111838
• Report Number: 2134265-2019-15148
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (y/n): N
• PMA/PMN Number: K151610
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024037624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FR ANGIOGRAPHIC CATHETER.; 4FR ANGIOGRAPHIC CATHETER.
• Patient Outcome(s): Required Intervention