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

Model Number	406180
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 10f fast-cath introducer sheath was received for evaluation.The dilator was also received.The sheath distal tip had been split; the sheath tubing was bent 3.11¿ and 9.58¿ from the distal tip.The sheath tubing had been kinked and punctured at 1.83¿ distal to the hemostasis hub and appeared to have been dissected from 1.91¿ through 2.12¿ distal to the hemostasis hub, which is consistent with the reported event.There was no visible dilator damage.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing damage is consistent with damage during use.
Event or Problem Description
During a procedure, blood was noted to be leaking from a tear in the shaft of the introducer.The introducer was replaced and the procedure was completed with no adverse patient consequences.

• 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: 10307104
• Report Number: 3005334138-2020-00275
• Device Sequence Number: 10963535
• Product Code: DYB
• UDI-Device Identifier: 05414734014410
• UDI-Public: 05414734014410
• 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): 07/22/2020

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: 06/30/2022
• Device Model Number: 406180
• Device Catalogue Number: 406180
• Device Lot Number: 7075318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: Other