MAUDE Adverse Event Report: CORDIS DE MEXICO SI AVANTI+ .035 F8 W/MINI GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 402608X

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17729661 was performed and it was found that no issues were noted that may be related to the reported complaint.The complaint evaluation is currently in progress.Additional information will be submitted within 30 days of completion of the complaint evaluation.

Event Description

As reported, the nurses opened an 8f sheath introducer avanti and found it to have some small bits stuck to the wire like small bits of glue so did not use it.

Manufacturer Narrative

Complaint conclusion: as reported, the nurses opened an 8f sheath introducer avanti and found it to have some small bits of glue therefore the user was not able to use the device.Attempts to gather further information were unsuccessful.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 17729661 was performed and it was found that the product history record review does not suggest that the event experienced by the customer could be related to the manufacturing process.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.The product instructions for use caution the user to not use the package if it is open or damaged.Based on the product history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.Should additional relevant information become available, a supplemental mdr will be filed.

• Brand Name: SI AVANTI+ .035 F8 W/MINI GW
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 7589960
• MDR Text Key: 110708723
• Report Number: 9616099-2018-02187
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 402608X
• Device Catalogue Number: 402608X
• Device Lot Number: 17729661
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/17/2018
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1