MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI PLUS; CARDIOLOGY VASCULAR ACCESS (DRE)

Catalog Number 504605X

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

As reported, during a product inspection by the local authority the following products did not pass the conformity testing during their sanitary analysis due to the presence of filaments in the sterile packaging.The products were rejected and were not clinically used.There was no reported patient injury.Additional information received indicated that there was no damage noted to the shipping box or inner box.The laboratory found what they called "a filament of dubious nature within the sterile packaging." the integrity of the sterile pouch was not compromised.The product issue was noted at the laboratory of control (tunisian authorities).No pictures are available.The products are being returned.Various lot numbers were affected.No additional information is available.

Manufacturer Narrative

(b)(6).The products are available for evaluation and testing.However, the products have not been returned as of to date.This is one of five (5) complaint products affected, please reference mfr.Report # 9616099-2015-00147; 9616099-2015-00149; 9616099-2015-00150; 9616099-2015-00151; and # 9616099-2015-00152.

Manufacturer Narrative

Review of lot 17075530 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.No units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.No nonconformance records were issued for this lot.No excursions were found for lot 17004086.The products are available for evaluation and testing.However, the products have not been returned as of to date.This is one of five (5) complaint products affected, please reference mfr.Report # 9616099-2015-00147; 9616099-2015-00149; 9616099-2015-00150; 9616099-2015-00151; and # 9616099-2015-00152.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, during a product inspection by the local authority, the following products did not pass the conformity testing during their sanitary analysis due to the presence of filaments in the sterile packaging.The products were rejected and were not clinically used.There was no reported patient injury.Additional information received indicated that there was no damage noted to the shipping box or inner box.The laboratory found what they called "a filament of dubious nature within the sterile packaging." the integrity of the sterile pouch was not compromised.The product issue was noted at the laboratory of control.As per the tunisian authorities, the products will not be returned for analyses.(b)(4) - the complaint devices were not returned for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.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.Based on the manufacturing review and inability to retain products, there is no indication that the event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.This is one of five (5) complaint products affected, please reference mfr.Report # 9616099-2015-00147; 9616099-2015-00149; 9616099-2015-00150; 9616099-2015-00151; and # 9616099-2015-00152.

• Brand Name: SI AVANTI PLUS
• Type of Device: CARDIOLOGY VASCULAR ACCESS (DRE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4649013
• MDR Text Key: 5595778
• Report Number: 9616099-2015-00150
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 504605X
• Device Lot Number: 17075530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1