MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG INSERTION KIT GUIDEWIRE

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2015

Event Type  Injury  

Event Description

It was reported that upon insertion of the hls dilator kit, the wire that was included kinked upon use.The wire was replaced with another wire that was stiffer and facilitated the insertion process without further incident.The customer was not sure which model was used; either pik100 or pik 150.(b)(4).

• Brand Name: INSERTION KIT GUIDEWIRE
• Type of Device: INSERTION KIT GUIDEWIRE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt NJ ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4805169
• MDR Text Key: 5923808
• Report Number: 3008355164-2015-00109
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2015,05/01/2015

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention