MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX¿ SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED; CATHETERS AND ACCESSORIES

Catalog Number 50328-07

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the catheter being difficult to retract through the concomitant device could not be confirmed.The partial 30 cm portion of the triox catheter, which appears to have been cut, was visually examined and no surface anomalies, stretch marks or indentations were observed across the catheter.The investigation found no evidence the partially returned device components, features and or functions caused or contributed to the event.The catheter was measured length wise and there was no indication that it was stretched during use.The outer diameter of both the balloon and the catheter were measured and both meet product specifications.The remaining 80 cm of catheter, the hub and the proximal tubing connectors were not returned for investigation.The returned cordis device was also examined and no visually anomalies were observed that could have prevented extracting the catheter.The 30 cm portion of the catheter was pushed into the introducer and was able to be retracted without difficulty.The reported complaint could not be replicated with the indentured partial catheter and introducer.Additionally, the event describes what appears to be a ¿knotting¿ condition which is a known inherent risk associated with this procedure.Knotting can occur with any flow-directed pulmonary artery catheter.The directions for use (dfu) addresses this condition and provides instructions, recommendations and clinical references that would address this occurrence.

Event Description

User facility medwatch was received that stated the following: ¿anesthesia provider was inserting a pulmonary artery catheter when it became difficult to retract.The catheter could be advanced, just not retracted.The inability to place the catheter in the desired anatomical position resulted in the anesthesia provider attempting to withdraw the catheter.The catheter could not be discontinued and removed without the cordis as well¿.It was also reported that the event occurred during insertion of a pulmonary artery catheter.There was no adverse event reported.No additional information is known at this time.

• Brand Name: TRIOX¿ SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED
• Type of Device: CATHETERS AND ACCESSORIES
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: emily arnould ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8609087
• MDR Text Key: 145775611
• Report Number: 1713468-2019-00015
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619059835
• UDI-Public: (01)00840619059835(17)200601(10)3914350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2019

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: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 50328-07
• Device Lot Number: 3914350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR