MAUDE Adverse Event Report: CORDIS CORPORATION 5F TEMPO .038 80CM HEPATIC; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SRD5601

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17850156 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, it was found that there was a white powdery foreign material in the packaging of 5f.038 80cm tempo diagnostic catheter.The hospital had confirmed, the outer packaging was broken.The device could not be used for the patient due to this issue.To complete the procedure, another angiographic catheter was used.There was no reported patient injury.The device will not be returned for evaluation as it was discarded.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, and h6 have been updated accordingly.As reported, it was found that there was a white powdery foreign material in the packaging of 5f.038 80cm tempo diagnostic catheter.The hospital had confirmed, the outer packaging was broken.The device could not be used for the patient due to this issue.To complete the procedure, another angiographic catheter was used.There was no reported patient injury.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 17850156 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device 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.Shipping/handling or storage factors may have contributed to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿this product is designed and intended for single use.It is not designed to undergo reprocessing and re-sterilization after initial use.Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.Do not expose to organic solvents.Store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Exposure to temperatures above 54oc (130of) may damage the catheter.¿ neither the phr review nor the information available suggest that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 5F TEMPO .038 80CM HEPATIC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9513252
• MDR Text Key: 199991348
• Report Number: 9616099-2019-03430
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032063095
• UDI-Public: 20705032063095
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: SRD5601
• Device Catalogue Number: SRD5601
• Device Lot Number: 17850156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR