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

Model Number	406133
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One 9.5f fast-cath introducer sheath was received for evaluation.The sheath tube had been torn and detached 3.30¿ proximal to the distal tip.Functional testing was not possible due to the aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tear and detachment is consistent with damage during use.The cause of the dilator insertion difficulty and introducer withdrawal difficulty remains unknown.
Event or Problem Description
During a left atrial flutter ablation procedure, resistance was noted when inserting the dilator into the introducer.When attempting to withdraw the introducer in a twisting motion, the distal end of the sheath separated approximately 1 cm from the proximal end.The proximal end was unable to be retrieved from the patient so surgical intervention was performed to remove the remaining portion of the introducer.The patient remained in stable condition throughout.

• 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: 9971578
• Report Number: 3005334138-2020-00163
• Device Sequence Number: 2547149
• Product Code: DYB
• UDI-Device Identifier: 05414734009843
• UDI-Public: 05414734009843
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/17/2020

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: 07/31/2022
• Device Model Number: 406133
• Device Catalogue Number: 406133
• Device Lot Number: 7153814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/17/2020
• 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: Required Intervention