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

Model Number	406244
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-abbott 6fr diagnostic electrophysiology (ep) catheter was attempted to be used with a 7fr fast-cath hemostasis introducer; however, resistance was met.The ep catheter was removed and the dilator and guidewire of the fast-cath introducer was reintroduced but had also met resistance.Therefore the device was removed.Upon removal, the device broke into two pieces leaving the distal part inside the patients left femoral vein.Since the device was unable to be retrieved, a cut-down surgery was performed and the distal part of the device was removed.The incision site was sutured closed and the procedure was cancelled.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.
Additional Manufacturer Narrative
The reported event of the sheath breaking into two pieces was confirmed.The sheath tubing had been stretched, twisted, torn and separated.The sheath distal tip had been split and the proximal end of the sheath had been bent and gouged.The sheath distal tip inner diameter measurement was inconclusive due to the aforementioned damage.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the torn sheath is consistent with damage during use.The fast-cath introducers instructions for use (ifu) recommends the user advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.

• 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: 7996780
• Report Number: 3005334138-2018-00372
• Device Sequence Number: 1301711
• Product Code: DYB
• UDI-Device Identifier: 05414734014670
• UDI-Public: 05414734014670
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 406244
• Device Catalogue Number: 406244
• Device Lot Number: 6491668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention