MAUDE Adverse Event Report: PIK 150-USA # INSERTION KIT GUIDEWIRE 150

Device Problems Bent (1059); Kinked (1339)

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

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

The device was discarded, so the kink caused by the wire insertion being too stiff can not be confirmed.Maquet cardiopulmonary ag will continue to monitor incoming reports for any trends to determine if further action is necessary.A supplemental medwatch will be submitted if additional information becomes available.(b)(4).

• Brand Name: PIK 150-USA # INSERTION KIT GUIDEWIRE 150
• Type of Device: PIK 150-USA # INSERTION KIT GUIDEWIRE 150
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 222932112
• MDR Report Key: 4606152
• MDR Text Key: 5628204
• Report Number: 8010762-2015-00268
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1