MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a ffr comet wire in two pieces.Visual inspection of the device revealed slight bends throughout the device which could appear from normal use.The guidewire was completely separated 12.75cm from the distal tip.The proximal fracture to the seam weld was 25.5cm.There also was a bend at 19cm from the seam weld on the wire.The magnified inspection of the fractured surface appears to be consistent with separation due to ductile bending overload.The batch is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a guidewire fracture occurred.Vascular access was obtained via a left radial approach.A 6f guide catheter was advanced into the right coronary artery (rca).A non-bsc guidewire was advanced into the rca.Ivus imaging revealed disease.The physician wanted to evaluate the vessel with ffr technology.The ivus catheter was withdrawn and advanced the comet wire through the guide, at which point the physician disengaged the guide to equalize into the aortal.Recannulated the rca and tried to advance the wire and realized that it would not advance.After withdrawing the comet, they realized that it wasn't withdrawing from the distal portion and it had separated inside the guide catheter with the distal portion still hanging outside into the aorta.They pulled back the non-bsc guidewire and realized when they pulled the non-bsc wire, the distal portion of the comet retracted as well, suggesting it was wrapped around in the guide catheter.The non-bsc wire was withdrawn which brought the distal portion of the comet back into the guide catheter.They withdrew the guide catheter and everything as one unit and aborted the case with no intervention performed.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Method codes updated.Device evaluated by mfr: mtac results revealed the fracture surfaces exhibit dimples.Fracture specimens exhibit bend.A foreign substance was present on the distal end of the fracture face that was found contain carbon, iodine, sodium, chloride, and other trace elements.Composition of the foreign residue found on the fracture face could be due to a saline solution and iodine contrast, which are typical components used in intervention.No surface abnormalities observed.(b)(4).

Event Description

It was reported that a guidewire fracture occurred.Vascular access was obtained via a left radial approach.A 6f guide catheter was advanced into the right coronary artery (rca).A non-bsc guidewire was advanced into the rca.Ivus imaging revealed disease.The physician wanted to evaluate the vessel with ffr technology.The ivus catheter was withdrawn and advanced the comet wire through the guide, at which point the physician disengaged the guide to equalize into the aortal.Recannulated the rca and tried to advance the wire and realized that it would not advance.After withdrawing the comet, they realized that it wasn't withdrawing from the distal portion and it had separated inside the guide catheter with the distal portion still hanging outside into the aorta.They pulled back the non-bsc guidewire and realized when they pulled the non-bsc wire, the distal portion of the comet retracted as well, suggesting it was wrapped around in the guide catheter.The non-bsc wire was withdrawn which brought the distal portion of the comet back into the guide catheter.They withdrew the guide catheter and everything as one unit and aborted the case with no intervention performed.No patient complications were reported and the patient's status is fine.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5727426
• MDR Text Key: 47490609
• Report Number: 2134265-2016-04949
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

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 Model Number: H7495551110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1