MAUDE Adverse Event Report: CORDIS CORPORATION DGW .035 FC J3MM 175CM TEF; WIRE, GUIDE, CATHETER

Model Number 502585

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

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there appeared to be a ¿beast¿ in the package of a 3mm 175cm.035¿ emerald fixed-core j-curved diagnostic guidewire.It was discovered when the package was opened by the physician.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The product arrives at the pharmacy that serves as the receiving area of the device.The product is not exposed to long periods of sunlight.The humidity is not controlled in the room where the device was stored but only the temperature.The product is stored there a maximum of a few hours before it is distributed to the cath lab.There was no damage noted to the packaging of the device.The foreign body was found in the inner product pouch.Other additional procedural details were requested but were unknown.The device will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, there appeared to be a ¿beast¿ in the package of a 3mm 175cm.035¿ emerald fixed-core j-curved diagnostic guidewire.It was discovered when the package was opened by the physician.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The product arrives at the pharmacy that serves as the receiving area of the device.The product is not exposed to long periods of sunlight.The humidity is not controlled in the room where the device was stored but only the temperature.The product is stored there a maximum of a few hours before it is distributed to the cath lab.There was no damage noted to the packaging of the device.The foreign body was found in the inner product pouch.Other additional procedural details were requested but were unknown.The device was not returned for analysis.A product history record (phr) review of lot 35260367 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device or pictures for analysis, the reported customer event ¿packaging/pouch/box - foreign material - in sterile package¿ could not be confirmed and the exact root cause could not be determined.Storage or handling factors may contribute to this type of event.According to the ifu, which is not intended as a mitigation of risk, ¿prior to use and when possible during the procedure, inspect the guidewire carefully for signs of damage.Do not use a guidewire that shows signs of damage.Store in a cool, dark, dry place.Do not use if package is open or damaged.Use prior to ¿use by¿ date.Do not expose to organic solvents.Exposure to temperatures above 54oc (130of) may damage the components.Movement of torque device or metal insertion tool on a guidewire's coating may compromise the integrity of the coating.¿ neither the phr review nor the information available suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: DGW .035 FC J3MM 175CM TEF
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9467365
• MDR Text Key: 191166539
• Report Number: 1016427-2019-03667
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K864058
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 502585
• Device Catalogue Number: 502585
• Device Lot Number: 35260367
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1