MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406114
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported air leak could not be conclusively determined.The fast-cath instructions for use (ifu) cautions the user to withdraw components slowly (withdraw the needle slowly from the dilator and withdraw the dilator slowly from the sheath) to minimize the vacuum created during withdrawal.All air should be aspirated slowly from the sheath using a syringe attached to one of the sideports of the three-way stopcock.Also the dilator, sheath, and catheter should be frequently flushed with saline to minimize the potential for air emboli.
Event or Problem Description
During an iabp (intraaortic balloon pump) procedure, an air leak was noted.Following insertion into the patient, air was aspirated into the syringe connected to the extension port of the sheath.Several aspirations were attempted with no resolution.The sheath set was replaced and the procedure was completed with no adverse consequences to the patient.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8126302
• Report Number: 3005334138-2018-00467
• Device Sequence Number: 11344169
• Product Code: DYB
• UDI-Device Identifier: 05414734013932
• UDI-Public: 05414734013932
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 406114
• Device Catalogue Number: 406114
• Device Lot Number: 6298701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1