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

Model Number 70105.3069

Device Problems Bent (1059); Kinked (1339)

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

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that during patient treatment and while inserting the cannula of the pik 150-usa#insertion kit, the wire kinked.It was assumed that the cannula/wire combination was not stiff enough and an amplatzer super stiff wire would be the correct one.Therefore, a second kit was opened which instead, contained an amplatzer super stiff wire which was used to insert the dilator set into the patient.No further complications were noted.(b)(4).Reference mfr # 8010762-2015-00268.

• Brand Name: PIK 150-USA # INSERTION KIT GUIDEWIRE 150
• Type of Device: PIK 150-USA # INSERTION KIT GUIDEWIRE 150
• Manufacturer (Section D): MAQUET CARDIOPULMOMARY AG; rastatt ; 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: 4606187
• MDR Text Key: 15222935
• Report Number: 3008355164-2015-00044
• 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: 03/13/2015,02/12/2015

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
• Device Model Number: 70105.3069
• Device Catalogue Number: PIK 150-USA#INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 172