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 Type  Injury  

Event Description

Please see importer report #: (b)(4).

Manufacturer Narrative

Maquet (b)(4), usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).Maquet did not receive the device for evaluation, nor any info as to the article or lot.Without this info an investigation could not be performed.Based on the info received the actual cause of the event could not be identified.A supplemental medwatch will be provided if additional info becomes available.(b)(4).

• Brand Name: INSERTION KIT GUIDEWIRE
• Type of Device: INSERTION KIT GUIDEWIRE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 9722293211
• MDR Report Key: 4805164
• MDR Text Key: 18663429
• Report Number: 8010762-2015-00671
• 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: Health Professional,User Facility,Company Representative
• 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: 05/01/2015
• Initial Date FDA Received: 05/28/2015
• 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