MAUDE Adverse Event Report: CORDIS DE MEXICO SABER RX8MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51008004L

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported during incoming inspection, there was an incision on the upper part of the sterilized pouch of the saber rx8mm4cm155 (it was perforated).There was no patient injury as the defect was found during incoming inspection.The sealing label was triple (normally it one layer or two), and the pouch was horizontal compare to the other pouches (turned 90 degrees angle) in the box.A worker noticed the defect during removal of instruction for use (ifu).The box which contained the defected product was inspected and no anomalies and incision were confirmed.

Manufacturer Narrative

During incoming inspection, there was an incision on the upper part of the sterilized pouch of the saber r x 8 mm x 4 cm 155 cm (it was perforated).There was no patient injury as the defect was found during incoming inspection.The sealing label was triple (normally it is one layer or two), and the pouch was horizontal compare to other pouches (turned 90 degrees angle) in the box.A worker noticed the defect during removal of instruction for use (ifu).The box which contained the defected product was inspected and no anomalies and incision were confirmed.It is unknown if the product was damaged.The device was returned for analysis.One non-sterile unit of saber r x 8 mm x 4 cm 155 cm balloon catheter was returned in its original inner pouch inside of its original box that was found opened at the ¿open here¿ label side.Per visual analysis the inner package was received with a rupture typically caused by a sharp object; however the sealed areas were inspected and the pouch was found properly sealed.No anomalies or damages were found on the saber unit.A meeting was held with the saber engineering team to review the received pouch and during the meeting the damage on the pouch was confirmed.However, the source of the damage was not determined; therefore an investigation of the manufacturing process was performed with the following results: ¿after the investigation assessment it is concluded that there is a possibility that a pouch can be damaged, in a similar manner to the one received from the distribution center, during the manufacturing process of the saber product.¿ a device history record (dhr) review of lot 17617050 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/ pouch/box - compromised sterility - sterile barrier breached¿ and ¿packaging/ pouch/box ¿ frayed/split/torn - inner package¿ was confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.The source of the rupture could be related to a sharp object.Since the product outer box was received opened, it cannot be determined if the damage of the pouch occurred during the manufacturing process or when inspected at incoming inspection as it is described in the complaint description summary.The product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore a corrective/preventive action will be taken at this time.An awareness training was provided by pet to the saber associates to prevent this kind of issue recurring.

• Brand Name: SABER RX8MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6372005
• MDR Text Key: 68842268
• Report Number: 9616099-2017-00933
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51008004L
• Device Catalogue Number: 51008004L
• Device Lot Number: 17617050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/03/2017
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1