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

Model Number 8900

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 07/22/2019

Event Type  Injury  

Event Description

It was reported that a wire break occurred.Vascular access was obtain via the left radial artery.This comet pressure guidewire was selected and successfully advanced into the right coronary artery (rca) with identified an fractional flow reserve (ffr) value of.78 and 50% stenosis.The unspecified guide catheter and comet guidewire were removed and were re-inserted into the left circumflex artery (lcx) with the identified ffr value of 0.7 and 50% stenosis.The devices were removed again and were re-inserted into the left anterior descending (lad).The lesion was very narrow, moderately tortuous, and severely calcified.They attempted to advance the comet guidewire without success, significant torque/rotation was applied midway without a response.The comet guidewire was pulled back, when they identified a separation approximately 21 cm from the distal tip, which remained inside the patient.A kink was also identified proximal to the separation.A retrieval technique using a non-bsc microcatheter was successfully performed to remove the separated portion.It was noted that the tip of the guide/diagnostic catheter maintained position in the ostium throughout the entire procedure.No further patient complications occurred and the patients status is good.

Manufacturer Narrative

The returned product consisted of an ffr comet wire, it was noticed that the device was separated when returned.The designed length of the comet wire is 185cm.The returned portion of the device measured 158.4cm which means that 26.6cm was not returned.The wire showed multiple bends.A kink located 4cm from the separated end was also noticed.Bench testing could not be performed due to the damage of the device.A scanning electron microscopy (sem) analysis was performed which identified that multiple fracture locations were present.Fatigue striations on the beam surface of the bottom ring indicate reverse bending fatigue.Microvoid coalescence suggest final rupture may have been caused by ductile overload.The beam does not appear to be abnormally narrow.Ring location failure modes are unknown, but smeared metal on one location shows a torsional pattern; suggesting torsional loads/stresses were present after failure.A crack was present on the bottom ring propagating axially along the tube.No other damage or irregularities were noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that a wire break occurred.Vascular access was obtain via the left radial artery.This comet pressure guidewire was selected and successfully advanced into the right coronary artery (rca) with identified an fractional flow reserve (ffr) value of.78 and 50% stenosis.The unspecified guide catheter and comet guidewire were removed and were re-inserted into the left circumflex artery (lcx) with the identified ffr value of 0.7 and 50% stenosis.The devices were removed again and were re-inserted into the left anterior descending (lad).The lesion was very narrow, moderately tortuous, and severely calcified.They attempted to advance the comet guidewire without success, significant torque/rotation was applied midway without a response.The comet guidewire was pulled back, when they identified a separation approximately 21cm from the distal tip, which remained inside the patient.A kink was also identified proximal to the separation.A retrieval technique using a non-bsc microcatheter was successfully performed to remove the separated portion.It was noted that the tip of the guide/diagnostic catheter maintained position in the ostium throughout the entire procedure.No further patient complications occurred and the patients status is good.

• 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: 8885120
• MDR Text Key: 154025345
• Report Number: 2134265-2019-09600
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0023689671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention