MAUDE Adverse Event Report: ICU MEDICAL, INC. OPTIQ, SVO2/CCO CATHETER

Model Number 52510-14

Device Problems Difficult To Position (1467); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

Int'l (b)(6) complaint received reporting placement difficulties with use of one (1) 52510-14, 8f optiq, svo2/cco j-tipped catheter.The initial information received reports at an unspecified time during the procedure doctor was " unable to adjust advancement, had to remove the whole catheter".The 52510-14 catheter would have been pre-tested prior to placement.There were no reported adverse patient consequences.Additional relevant event/usage information although requested by the manufacturer has not been provided.Device return: one used 52510-14 catheter was received.Qe investigation is in progress.

Manufacturer Narrative

Visual analysis: 11/2/2015 - received one (1) used 52510-14, 8f optiq, svo2/cco j-tipped catheter lot# 2829041.A touch contamination shield and a y-site adapter were added to the catheter which a covers the catheter from approximately the 10cm mark to the 90cm mark.Blood was visible on the catheter and in the y-site adapter.Test results: catheter was visually inspected and then was worked for actuation through introducer and contamination sheath.Through careful inspection the catheter tubing was inspected no kinks or anomalies were observed.Upon receipt it was observed that the catheter could not move back and forth through the introducer and sheath.It was observed that the twisting connection of both ends of the contamination sheath were tightened to not allow movement of the catheter.Once the twisting connection was loosened that catheter was able to easily slide back and forth through the introducer and contamination sheath.Unit was also leak tested and flow tested.No leaking was observed during leak testing.Flow rate for distal luman was 3.77 ml/min proximal lumen was 9.37 ml/min and dtp lumen was 3.66 ml/min.Each flow rate for all three lumen passed specification testing.Balloon was inflated and inspected for symmetry and leaking.Balloon passed all inspections for inflation, deflation,symmetry, and diameter (0.527in) requirements.Catheter lumen diameter was measured.No failure was observed.Catheter lumen passed specification testing.Analysis summary: the reported complaint could not be confirmed.It is unclear if the catheter was unable to advance due to the tightened connections of the contamination sheath or from some difficulty of the patient's anatomy.The difficulty of insertion could not be contributed to any functional performance of the catheter.

• Brand Name: OPTIQ, SVO2/CCO CATHETER
• Type of Device: OPTIQ, SVO2/CCO 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: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5225009
• MDR Text Key: 31334649
• Report Number: 2025816-2015-00117
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K06299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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: 10/01/2015
• Device Model Number: 52510-14
• Device Catalogue Number: 52510-14
• Device Lot Number: 2829041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1