MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 6F STD W/O GW&OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504606A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information to include from section e facility name: phone number: (b)(6).A device history record (dhr) review could not be conducted as the sterile lot number was not provided.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During use, it was reported that the avanti sheath "broke off" and the patient went into "af".The sheath was recovered and there was no patient injury.
Additional Manufacturer Narrative
Additional information was received via email and the ir retrieved the sheath tip with a snare from the right ventricle.Three sheaths were used into the femoral vein.No other information was provided.

• Brand Name: SI AVANTI+ 6F STD W/O GW&OBT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7650456
• Report Number: 9616099-2018-02220
• Device Sequence Number: 11140929
• Product Code: DRE
• UDI-Device Identifier: 20705032009994
• UDI-Public: 20705032009994
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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 Model Number: 504606A
• Device Catalogue Number: 504606A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/30/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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
• Patient Age: 48 YR