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

Model Number	406128
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure the introducer was being used to insert and advance the cardiomems delivery catheter system.At the end of a procedure, upon removal of the sheath from the patient's right femoral vein, the distal portion of the sheath remained in the vessel while the proximal portion was retracted and removed.A snare was used to remove the remainder of the device.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One 12f, fast-cath introducer hemostasis sheath was received for evaluation.The results of the investigation concluded that the sheath tubing had been stretched, torn and separated into two sections, distal to the hemostasis hub.The detached tubing had been creased and folded inward, and had been flattened, stretched and torn at the proximal end.The attached tubing distal end appearance had similar damage, consistent with a mating surface to the aforementioned detached tubing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath damage is consistent with damage during use.

• 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: 7995642
• Report Number: 3005334138-2018-00378
• Device Sequence Number: 16193821
• Product Code: DYB
• UDI-Device Identifier: 05414734008280
• UDI-Public: 05414734008280
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/14/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 406128
• Device Catalogue Number: 406128
• Device Lot Number: 5601603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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: Required Intervention
• Patient Age: 74 YR