MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PICCO CATHETER; PROBE, THERMODILUTION

Model Number	PV2014L16-A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6).On may 17th, after catheter was inserted, blood loss was detected.User tried to stop the bleeding by using a bandage.On may 20th, when opening the bandaging, it was detected that the catheter has ruptured near the puncture site, causing bleeding.Catheter was removed.No serious injury reported.
Additional Manufacturer Narrative
Further information about the event has been requested.Supplemental emdr will be sent when the investigation is completed.H3 other text : device not yet received.
Additional Manufacturer Narrative
It was reported that the picco catheter pv2014l16-a has ruptured at the puncture site, causing bleeding.After the visual and subsequent microscopic examination of the retained sample of the same lot/batch, no deviation or rupture signs could be determined.A dhr check did not identify any deviations or non-conformities related to the failure description.With the information stated above the complaint will be closed.Date of event according to customer: 05/17/2023 h3 other text : device requested but discarded by user.
Event or Problem Description
Manufacturer ref.: (b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 17348366
• Report Number: 3003263092-2023-00005
• Device Sequence Number: 5152273
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)260930(11)211014(10)696171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 696171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 60 KG