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

Model Number	8900
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of an ffr comet pressure wire connected to the occ cable.Shaft was separated.Both the tip and the proximal shaft were returned.The devices shaft was visually and microscopically inspected for damage.The device showed a separation located approximately 3.4cm from the tip.The tip was damaged with a kink.The shaft showed multiple small bends.There was a kink located at the occ handle.The separated end looks to have been caused by bending force break.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.The pressure wire was connected to the analysis support test bench and all applicable data was correct pertaining to coefficient values; however, the signal/modulation could not be validated due to the separated distal end.The coefficient was confirmed and met specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that a guidewire detachment occurred.Vascular access was obtained via the right radial artery.The comet pressure guidewire was prepped and was inserted through a non-bsc diagnostic catheter.During advancement into the right coronary artery(rca), an angiogram revealed that the tip of the comet wire prolapsed while in the 2-2.5mm in diameter distal posterior left ventricular wall.Fractional flow reserve (ffr) measurements were successfully taken of the rca.The comet pressure wire and diagnostic catheter were removed.A decision was then made to ffr the left circumflex artery.Prior to re-insertion they found that the comet wire was bent.Using an introducer tool the comet wire was straightened out and reshaped.The comet wire, along with a 3.5 fr non-bsc guide catheter were then re-inserted into the 50% stenosed,non-tortuous and non-calcified,10mm in length left circumflex artery.While advancing the comet wire 3-4mm into the lad, the wire prolapsed at the sensor.While pulling back the comet wire the sensor hit the 3.5 fr non-bsc guide catheter and a tip separation occurred.A snare was used to successfully remove the wire tip.All parts of the device were removed from the patient.The procedure was not completed and no further patient complications were reported.

• 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: 9168313
• Report Number: 2134265-2019-12083
• Device Sequence Number: 1801343
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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 Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024207436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIAGNOSTIC CATHETER: DIAGNOSTIC JR4; GUIDE CATHETER MEDTRONIC EBU 3.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR