MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F OPTIQ CATHETER

Model Number 52510-12

Device Problems Balloon leak(s) (1052); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2013

Event Type  malfunction  

Event Description

((b)(6)) complaint received concerning balloon failure with use of one 52510-12 8f optiq heparin coated catheter.The distributors' report states "balloon deflated after insertion." there were no reported adverse pt outcomes.Although requested, add'l incident info and device return requests have, to date, been unsuccessful.Lot build record review: a review of the mfg lot build records was performed for the reported lot #28-738-sl (mfg 05/2013) which showed (b)(4) units were manufactured, tested, inspected, and released.The lot build records showed all visual, dimensional, and functional qc lot testing met all specs.There was no exception or rejection documentation generated during the mfg lot build.

• Brand Name: 8F OPTIQ CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3938256
• MDR Text Key: 4530537
• Report Number: 2025816-2014-00017
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52510-12
• Device Catalogue Number: 52510-12
• Device Lot Number: 28-738-SL
• Other Device ID Number: PR#23328
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/02/2013
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1