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

Model Number SL1¿

Device Problems Entrapment of Device (1212); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Event Description

Patient was undergoing radiofrequency cardiac ablation procedure in ep lab when the sl1 8.5 dilator became stuck within the sheath.The doctor was using the biosense thermocool ablation catheter for this ablation procedure.Two sl1 8.5 dilators were opened for this procedure from two different lot numbers.We are unable to determine which lot this defective sl1 8.5 dilator came from.Ablation procedure was able to be completed without harm to the patient.Manufacturer response for introducer, catheter, fast-cath¿ (per site reporter): sl1 8.5 f dilator given to company rep.

• Brand Name: FAST-CATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 6968079
• MDR Text Key: 89928435
• Report Number: 6968079
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: (01)05414734203388
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: SL1¿
• Device Catalogue Number: 406849
• Device Lot Number: 5999014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH
• Patient Age: 73 YR