MAUDE Adverse Event Report: CORDIS US. CORP POWERFLEX PRO; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400504S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is related to report # 3007635982-2023- 00275, 3007635982-2023-00276, 3007635982-2023-00277, 3007635982-2023-00278, 3007635982-2023-00279, 3007635982-2023-00280, 3007635982-2023-00281, 3007635982-2023-00282, 3007635982-2023-00283.A review of the manufacturing documentation associated with lot 82264190 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 or Problem Description
As reported, the facility received 10 powerflex pro balloons (multiple sizes) that were contaminated with dirt particles either in box and or packaging.For fear of contaminating sterile field, two of these balloons that were going to be used did not get opened because procedural person noticed the dirt prior to opening.Upon further inspection of remaining balloons, they discovered that an additional 8 balloons were similarly contaminated.There was no reported injury to the patient.It is unknown if the dirt particles were within the sealed portion of the packages.The facility does not have a receiving bay.The devices were stored for approximately one month prior to use.There were no damages noted to the shipping boxes.There was no damage noted to the actual device packaging.The devices will be returned for evaluation.
Additional Manufacturer Narrative
This report is related to report # 3007635982-2023-00275, 3007635982-2023,00276, 3007635982-2023-00277, 3007635982-2023-00278, 3007635982-2023-00279, 3007635982-2023-00280, 3007635982-2023-00281, 3007635982-2023-00282, 3007635982-2023-00283.The facility received 10 powerflex pro balloons (multiple sizes) that were contaminated with dirt particles either in box and or packaging.For fear of contaminating sterile field, two of these balloons that were going to be used did not get opened because procedural person noticed the dirt prior to opening.Upon further inspection of remaining balloons, they discovered that an additional 8 balloons were similarly contaminated.There was no reported injury to the patient.It is unknown if the dirt particles were within the sealed portion of the packages.The facility does not have a receiving bay.The devices were stored for approximately one month prior to use.There were no damages noted to the shipping boxes.There was no damage noted to the actual device packaging.A non-sterile powerflexpro 5mm x 4cm 80cm bc was received inside the corresponding packaging box.The box was not sealed and denoted evidence of being previously open outside of the cordis controls.No evidence of damage or contamination could be found in this evaluation.A product history record (phr) review of lot 82253626 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 contaminated¿ was not confirmed through analysis of the returned devices as the boxes received did not show any evidence related to the reported contamination.The exact cause of the event could not be determined during analysis.Based on the information available for review, shipping or handling factors may have contributed to the event.According to the safety information in the instructions for use, ¿do not use if package is damaged.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the facility received 10 powerflex pro balloons (multiple sizes) that were contaminated with dirt particles either in box and or packaging.For fear of contaminating sterile field, two of these balloons that were going to be used did not get opened because procedural person noticed the dirt prior to opening.Upon further inspection of remaining balloons, they discovered that an additional 8 balloons were similarly contaminated.There was no reported injury to the patient.It is unknown if the dirt particles were within the sealed portion of the packages.The facility does not have a receiving bay.The devices were stored for approximately one month prior to use.There were no damages noted to the shipping boxes.There was no damage noted to the actual device packaging.The devices will be returned for evaluation.
Additional Manufacturer Narrative
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 or Problem Description
As reported, the facility received 10 powerflex pro balloons (multiple sizes) that were contaminated with dirt particles either in box and or packaging.For fear of contaminating sterile field, two of these balloons that were going to be used did not get opened because procedural person noticed the dirt prior to opening.Upon further inspection of remaining balloons, they discovered that an additional 8 balloons were similarly contaminated.There was no reported injury to the patient.It is unknown if the dirt particles were within the sealed portion of the packages.The facility does not have a receiving bay.The devices were stored for approximately one month prior to use.There were no damages noted to the shipping boxes.There was no damage noted to the actual device packaging.The devices will be returned for evaluation.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17639056
• Report Number: 3007635982-2023-00284
• Device Sequence Number: 12746746
• Product Code: LIT
• UDI-Device Identifier: 20705032059326
• UDI-Public: (01)20705032059326(17)251031(10)82264190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 4400504S
• Device Lot Number: 82264190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/06/2023; 10/24/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/02/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown