MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿TRIO INTRODUCER, 10F, ACT; INTRODUCER, CATHETER

Model Number	406963
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 10.5f fast-cath trio introducer sheath and adaptor were received for evaluation.The sheath had been bent in multiple locations.The sheath hub separated from the sheath tubing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath detachment and bends is consistent with damage during use.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Following an atrial fibrillation ablation procedure, while removing the sheath from the patient, the trio hub was kinked and detached from the sheath.There was no resistance noted to remove the sheath.The procedure was completed without replacing the sheath.There were no adverse patient consequences.

• Brand Name: FAST-CATH¿TRIO INTRODUCER, 10F, ACT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9526923
• Report Number: 3005334138-2019-00990
• Device Sequence Number: 14147612
• Product Code: DYB
• UDI-Device Identifier: 05414734204057
• UDI-Public: 05414734204057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061015
• 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,Followup
• Report Date (Section B): 04/28/2020

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: 02/28/2022
• Device Model Number: 406963
• Device Catalogue Number: 406963
• Device Lot Number: 6921169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1