MAUDE Adverse Event Report: ICU MEDICAL, INC. CATH LAB KIT

Model Number 46098-75

Device Problem Component(s), broken (1103)

Patient Problems Distress (2329); Vascular System (Circulation), Impaired (2572)

Event Date 01/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the complaint database for this list#, lot# and similar issue recorded no additional reports.Findings: the involved 46098-75 device was not returned for analysis and confirmation.The exact causes of the reported event or the post incident/post procedure observation of a 46098-75 component (manifold) damage are unknown.

Event Description

Maude report received concerning component damage with use of 46098-75 cath lab kit.The report describes the event as follows "during an elective pci patient became nauseous and developed chest pains.Imaging post stent deployment showed that the patient had lost distal circulation on the left side.Patient was treated with intra-coronary nitroglycerin and iv zofran.Flow was restored and symptoms improved.Post procedure it was determined that the single manifold was cracked and had let some air in with the injection." the 46098-75 device would have been pre-tested/primed prior to use.During the emergent activity medications were successfully delivered/administered, patient returned to baseline condition and procedure resumed.The 46098-75 device remained in use with no reported device performance/functional issues encountered.Follow up with the facility for additional information as well as the return status of the 46098-75 device reports the device is not available and no additional information other than what was on the maude report.

• Brand Name: CATH LAB KIT
• Type of Device: CATH LAB KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT
• Manufacturer Contact: terry scesny ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4888495
• MDR Text Key: 24671093
• Report Number: 2025816-2015-00069
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46098-75
• Device Catalogue Number: 46098-75
• Device Lot Number: 2945128
• Other Device ID Number: PR # 30334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2015
• Distributor Facility Aware Date: 01/15/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2015
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1