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

Model Number SL1¿

Device Problems Scratched Material (3020); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

We have had multiple reports regarding st jude fast-cath sl1 8f 63cm trans septal introducer dilators having rough and jagged tips.These dilators compromise the introducers by catching at the end of the sheath thereby stretching and altering the smooth shape of the sheath.All were caught before reaching a patient and removed from the procedural field and replaced.

• Brand Name: FAST-CATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau pl.; minnetonka MN 55345
• MDR Report Key: 8850179
• MDR Text Key: 152917278
• Report Number: 8850179
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL1¿
• Device Catalogue Number: 406840
• Device Lot Number: 6831890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1