MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ .035 5F W/MINI GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	402605X
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the avanti sheath tip separated in the patient during removal.Physician explained the event that occurred to the patient and the extraction process.The radiologist surgeons and anesthesiologist were notified.
Additional Manufacturer Narrative
It was reported that the avanti sheath tip separated in the patient during removal.The physician explained the event that occurred to the patient and the extraction process.The radiologist surgeons and anesthesiologist were notified.Attempts to gather further information have been unsuccessful.  the product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the product instructions for use, users are cautioned that if increased resistance is felt upon insertion or withdrawal of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.Without a lot number to conduct a device history record review, it is not possible to determine if the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SI AVANTI+ .035 5F W/MINI GW
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6581173
• Report Number: 9616099-2017-01114
• Device Sequence Number: 13607117
• Product Code: DRE
• UDI-Device Identifier: 20705032000571
• UDI-Public: 20705032000571
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: 402605X
• Device Catalogue Number: 402605X
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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