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

Model Number PV2014L16-A

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event 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.

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.

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 Description

Manufacturer ref.: (b)(4).

• Brand Name: PICCO CATHETER
• Type of Device: 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
• MDR Text Key: 319531164
• Report Number: 3003263092-2023-00005
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)260930(11)211014(10)696171
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 60 KG