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

Model Number 50328-07

Device Problems Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

Lot# review: a review of lot# 3253340 showed that (b)(4) units were manufactured, tested, inspected and released in june 2016, citing no anomalies.Not returned.

Event Description

Complaint received regarding two 50328-07, triox svo2 pa catheter, 8fr, lot# 3253340 (mfd.06/2016).Report states; while insertion of the catheter, there seemed to be a kink near the thermistor that occurred.The doctor was unable to pull the catheter back through the cordis and they had to surgically remove the catheter.There were no adverse patient consequences reported.

• Brand Name: TRIOX SVO2 PA CATHETER, 8FR
• Type of Device: TRIOX SVO2 PA CATHETER, 8FR
• 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: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5993318
• MDR Text Key: 56178961
• Report Number: 2025816-2016-00157
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2016

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 Expiration Date: 11/01/2017
• Device Model Number: 50328-07
• Device Catalogue Number: 50328-07
• Device Lot Number: 3253340
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2016
• 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