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

Model Number H7495551110

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Udi= (b)(4).Device evaluated by mfr.: returned product consisted of a ffr comet pressure wire in one piece.A visual inspection showed that the tip showed no issues.The shaft showed one kink approximately 128cm from the tip.The shaft showed some peeling of the ptfe coating approximately 129cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 9/29/2016: it was reported that the comet pressure guidewire was kinked when it came out of the box.The wire did not enter the patients body and the procedure was completed with another comet wire.However upon analysis the comet wire it was shaft showed peeling of the ptfe coating.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6056961
• MDR Text Key: 58407600
• Report Number: 2134265-2016-09772
• 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: 09/29/2016

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 Expiration Date: 02/28/2017
• Device Model Number: H7495551110
• Device Lot Number: 19278541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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