MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB PICCO CATHETER; PROBE, THERMODILUTION

Model Number	PV2014L16-A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information about the event has been requested.A supplemental emdr will be sent when the investigation is completed.
Event or Problem Description
It was reported that a section of the picco guidewire sheared off and remained within a patient.Picco line inserted into right femoral artery.During initial and second it was impossible to pass guidewire and line became difficult to extract.Second clinician attempted to remove the line with gentle rotation.The wire was removed but on removal of the needle from the skin there was unraveled wire visible at the skin puncture site.Ultrasound and ct have confirmed part of the wire in the subcutaneous tissues and vessel.Final patient outcome is unknown.Manufacturer reference # (b)(4).
Event or Problem Description
Manufacturer's ref ot1433103.
Additional Manufacturer Narrative
The investigation is related to a picco catheter, in which it was reported that the guidewire became uncoiled and broke during retraction and remained within patient's body.A minor surgical intervention was planned to remove the remaining fragment from the patient¿s body.The investigation was performed in order to conduct analysis of that topic.On-site inspection and provided in record information confirmed the reported damaged guide wire.The faulty guide wire was sent for further investigation.Visual inspection of the returned part confirmed the reported issue; the guide wire was uncoiled.There is no indication for a systematic root cause as a deficiency of design, production or material.Picco catheters are used as accessories for thermodilution and arterial blood pressure measurement.The are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary.Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.However based on the available information and experience it can be concluded that the most probable cause of the issue was need to use excessive force to retract stuck guidewire.

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna 85622 ; GM 85622
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 23850467
• Report Number: 3013876692-2025-00106
• Device Sequence Number: 13154768
• Product Code: KRB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026
• Report Date (Section F): 07/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 801215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2026
• Device Age: 11 MO
• Date Report to Manufacturer: 07/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/16/2026