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

Model Number H7493932440

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the guidewire was returned for analysis.The tip, device shaft, sensor port and the coefficient values was examined for damage or any irregularities.The tip showed no issues.The shaft showed one kink approximately 29.5cm from the tip.The shaft showed some peeling of the polytetrafluoroethylene (ptfe) coating approximately 29.5cm from the tip.The sensor port was clear of any material.The complaint of a kink in the device was confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire.The coefficient was confirmed to be in specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 02/08/2017.It was reported that the guidewire kinked.A (b)(4) stenosed lesion was located in the moderately tortuous left anterior descending artery (lad).When removing and installing the optical cable, the comet wire kinked and was unable to be used.The procedure was not completed due to the patient's condition worsening (confirmed not related to the device malfunction).The cause of the worsening condition was "the blood of coronary artery became slow flow." therefore, the physician doubted vessel dissociation.The procedure was completed with stenting without ffr being performed and the patient's status was "no problem." device analysis revealed some peeling of the polytetrafluoroethylene (ptfe) coating approximately 29.5cm from the tip.

• 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: 6368766
• MDR Text Key: 68762760
• Report Number: 2134265-2017-01376
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

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 Expiration Date: 04/30/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 19545778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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