FDA Adverse Event Malfunction Summary report: N

COMET

MDR report key: 8544111 · Received April 24, 2019

Report

Report Number: 2134265-2019-04102
Event Type: Malfunction
Date Received: April 24, 2019
Date of Event: February 14, 2019
Report Date: April 24, 2019
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: DXO
UDI-DI: 08714729904397
PMA / PMN Number: K151610
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR THE RETURNED PRODUCT CONSISTED OF A FFR COMET PRESSURE WIRE NOT CONNECTED TO THE OCB CABLE. THE TIP, DEVICE SHAFT, SENSOR HOUSING AND THE COEFFICIENT VALUES WAS EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE SHAFT SHOWED A DETACHED TIP. THE DETACHED PORTION WAS 38CM LONG. THE SENSOR HOUSING WAS CLEAR OF BODY FLUIDS. THE SEPARATION IS CONSISTENT WITH THE REPORTED EVENT THAT THE WIRE GOT CAUGHT ON THE STRUT OF THE STENT. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING COULD NOT BE COMPLETED DUE TO THE SEVERITY OF THE DAMAGE.

Description of Event or Problem · 1

REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT IT WAS DIFFICULT TO CROSS THE LESION. A FFR PROCEDURE WAS BEING PERFORMED ON AN 80% STENOSED, SEVERELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE COMET PRESSURE GUIDEWIRE WAS INSERTED BUT COULD NOT CROSS THE LESION IN THE RCA WHERE A STENT WAS PREVIOUSLY IMPLANTED. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT TIP DETACHMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340247	COMET	TRANSDUCER, PRESSURE, CATHETER TIP	DXO	BOSTON SCIENTIFIC CORPORATION	8900	21898990	08714729904397

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR