MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F TRIOX SVO2 PA CATHETER

Model Number 50328-07

Device Problems Difficult to Insert (1316); Kinked (1339); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device return: one used 50328-07 catheter (partial segment) w/unmarked/unknown contamination shield/sheath accessory device.Engineering analysis: visual assessment (pre and post decontamination) of the returned partial catheter segment and attached contamination shield/sheath was performed.The report noted that the contamination shield/sheath hemostasis valves were observed to be in the locked position.After decontamination the contamination sheath was unlocked and the catheter was able to be inserted and removed thorough the contamination sheath and the introducer.When the contamination sheath was in the locked position the catheter would not insert was observed to kink.Two kink marks were observed on the distal end of the introducer approximately 1" from the tip.An indentation on the catheter segment was observed from the contamination sheath hemostasis lock.Findings: engineering analysis of the returned (partial) catheter segment and accessory devices were unable to confirm the reported product (kinking) and insertion issues.The triox catheter is a precision optical instrument and must be handled with care.Kinking, excessive manipulation, or grasping with forceps or hemostats can permanently damage the fiberoptics, components.Care should also be taken to remove any slack or loops in the catheter as this can also lead to migration.The 50328-07 catheter was pre-tested prior to placement with no issues detected at that time.The exact cause(s) of the reported event/product issue are unknown.

Event Description

Medsun report received concerning insertion/kinking problems with use of one 50328-07 8f triox svo2 pa heparin coated catheter.The medsun report describes the event as follows "the pulmonary artery catheter "kinked" while inserting it.It could not be moved through the cordis.The device was left in place and at the end of the case it was removed by removing the cordis at the same time.".The 50328-07 catheter was pre-tested prior to placement with no issues detected at that time.Additional event/device usage information although requested was unavailable.

• Brand Name: 8F TRIOX SVO2 PA CATHETER
• Type of Device: TRIOX SVO2 PA CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5498930
• MDR Text Key: 40280417
• Report Number: 2025816-2016-00018
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/03/2016

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
• Device Operator: Physician
• Device Model Number: 50328-07
• Device Catalogue Number: 50328-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2016
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CORDIS CONTAMINATION SHIELD/GUIDEWIRE
• Patient Age: 69 YR
• Patient Weight: 80