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

Model Number H7495551110

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a comet pressure guidewire.The tip, device shaft, sensor port and the coefficient values was examined for damage or any irregularities.The tip showed damage in the form bends/kinks.There was also a kink on the shaft approximately 92cm from the tip.It was noticed that some slight coating was peeling off of the shaft at the kinked area.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 most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

Reportable based on analysis completed on 26-oct-2017.It was reported that the wire tip came out damaged from packaging.A comet 185cm pressure guidewire came out damaged from packaging.The device did not enter the patients body.The procedure was completed with another comet pressure guidewire.There were no patient complications reported.However, returned device analysis revealed that slight coating was peeling off of the shaft at a kinked area.

• 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: 6997691
• MDR Text Key: 91330713
• Report Number: 2134265-2017-11150
• 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
• Report Date: 10/26/2017

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: 05/30/2019
• Device Model Number: H7495551110
• Device Lot Number: 0020708597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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
• Patient Age: 77 YR