MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX SVO2 PA HEPARIN COATED CATHETER

Model Number 50328-08

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation of the "as received" used 50328-08 catheter recorded the catheter balloon was extensively damaged/torn.This condition would result in the reported inflation failure.B)(4).Findings: visual analysis of the returned 50328-08 catheter confirmed the reported inflation failure.The root cause was attributable to extensive balloon damage/tears.The exact cause(s) of the component damage are unknown.The catheter device was pre-tested for inflation integrity prior to use, successfully inserted with no reported issues.The component damage most likely occurred as a result of incorrect technique/use of ancillary devices.This report and the associated data are entered in the mfgs.Database for continuous monitoring and trending.

Event Description

Complaint received reporting balloon inflation issue with use of one (1) 50328-08 8f triox svo2 heparin pa coated catheter.The initial information received reports " during a case,.The balloon would not expand on the opticath.Pulled it out for inspection,.Noticed a tear ".The catheter device was pretested prior to placement with no issues detected at that time.There were no patient injuries and or adverse outcomes.The involved 50328-08 catheter was returned to the manufacturer for analysis.

• Brand Name: TRIOX SVO2 PA HEPARIN COATED CATHETER
• Type of Device: TRIOX SVO2 PA HEPARIN COATED 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 ; 8014641400
• MDR Report Key: 5156673
• MDR Text Key: 28523933
• Report Number: 2025816-2015-00114
• 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,other
• Reporter Occupation: Other
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2016
• Device Model Number: 50328-08
• Device Catalogue Number: 50328-08
• Device Lot Number: 3063709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TERUMO RSS902 9F PINNACLE SHEATH
• Patient Age: 54 YR