MAUDE Adverse Event Report: CORDIS DE MEXICO SI AVANTI+ 7F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504607X
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.  device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the 7fr avanti sheath tip broke off (separated) while attempting to pull the sheath in the patient.Interventional radiology & fluoroscopy on the sheath was performed, the sheath tip was located and snared from the patient.
Additional Manufacturer Narrative
This report has been updated to include the additional information requested from the fda.The initial information regarding the request has been sent in the initial report however, the report number from the request wasn't included.The report number from the initial request is (b)(4).The additional information for this request is still on going as i am still following up on the additional information from the sales rep for the lot number, a complete description of the event, and distribution information.
Additional Manufacturer Narrative
It was reported that the 7fr avanti sheath tip separated while attempting to pull the sheath into the patient.An additional procedure was performed in order to locate and remove the tip by the use of a snaring device.Attempts to gather further information were 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 devices 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 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 as was done in this case.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 preventative actions will be taken at this time.  additional information requested is still pending and will be submitted once the additional information is received.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SI AVANTI+ 7F STD W/GW NO OBT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6431404
• Report Number: 9616099-2017-00991
• Device Sequence Number: 986742
• Product Code: DRE
• UDI-Device Identifier: 20705032010105
• UDI-Public: 20705032010105
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 06/02/2017

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: 504607X
• Device Catalogue Number: 504607X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/12/2017; 05/08/2017; 06/02/2017
• 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