MAUDE Adverse Event Report: CORDIS CORPORATION VASCULAR CLOSURE DEVICE 7F -; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

As reported, the inner product pouch seal of a 7f exoseal vascular closure device was open, and the sterile integrity was compromised.It was not possible that the product had been purposely opened in anticipation of use, and when not used was re-shelved.The damage was noted after the product had been received, and stored in the lab, prior to using.It was stored in the lab as usual, and the actual product was not damaged.The product was not used.There was no reported patient injury.The device is not being returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18036357 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, and h6.As reported, the inner product pouch seal of a 7f exoseal vascular closure device was open, and the sterile integrity was compromised.It was not possible that the product had been purposely opened in anticipation of use, and when not used was re-shelved.The damage was noted after the product had been received, and stored in the lab, prior to using.It was stored in the lab as usual, and the actual product was not damaged.The product was not used.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 18036357 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 - seal open¿ could not be confirmed as the product was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Based on the limited information provided it is impossible to determine what factors may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿do not use the exoseal vcd if the package is damaged or any portion of the package has been previously opened¿.Neither the phr review nor the information available suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: as reported, the inner product pouch seal of a 7f exoseal vascular closure device was open, and the sterile integrity was compromised.It was not possible that the product had been purposely opened in anticipation of use, and when not used was re-shelved.The damage was noted after the product had been received, and stored in the lab, prior to using.It was stored in the lab as usual, and the actual product was not damaged.The product was not used.There was no reported patient injury.The product was returned for analysis.A non-sterile vascular closure device 7f was received for analysis inside a plastic bag.Neither the inner product pouch nor any other packaging component was returned for evaluation.Per visual analysis, no anomalies found on the received exoseal vascular closure device.Microscopic analysis was not performed as neither inner product pouch nor any other packaging component was returned for evaluation.A product history record (phr) review of lot 18036357 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported by the customer as ¿packaging/pouch/box-compromised sterility - seal open¿ was not confirmed due to the condition of the unit returned (neither the inner product pouch nor any other packaging component was returned for evaluation).The exact cause of the reported event could not be conclusively determined.According to the instructions for use (ifu) which is not intended as a mitigation of risk, users are instructed not to use the device if the packaging is open.Neither the phr review nor the product analysis results suggest that the event reported could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: VASCULAR CLOSURE DEVICE 7F -
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14522588
• MDR Text Key: 294137090
• Report Number: 9616099-2022-05667
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10705032058896
• UDI-Public: (01)10705032058896(17)230630(10)18036357
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: EX700
• Device Lot Number: 18036357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 67 KG