MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	533552
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter telephone number: (b)(6).Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a hair strand was found inside of the sterile package of the 5.2f, 100cm super torque plus judkin's right (jr) 4 polyurethane diagnostic catheter.The procedure was completed with another cordis diagnostic catheter.There were no reports of patient injury.The package had not been opened by the customer.The seal of the inner package had not been opened.The condition was noted prior to using the product, after it had been received and stored in the lab.It was stored like all other products in the catheterization lab, with no other hairs detected.The actual product was not damaged.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h10 complaint conclusion: as reported, a hair strand was found inside of the sterile package of the 5.2f, 100cm super torque plus judkin's right (jr) 4 polyurethane diagnostic catheter.The procedure was completed with another cordis diagnostic catheter.There were no reports of patient injury.The package had not been opened by the customer.The seal of the inner package had not been opened.The condition was noted prior to using the product, after it had been received and stored in the lab.It was stored like all other products in the catheterization lab, with no other hairs detected.The actual product was not damaged.A sterile catheter ¿cath f5.2+ jr4 100cm¿ was received coiled inside of a clear plastic bag.The part was unpacked to proceed with the product evaluation.The catheter is inside a pouch properly sealed, and the sterility is not compromised.The pouch was inspected observing a hair trapped between the catheter and the mounted card.The sealed and sterile pouch was inspected with a vision system confirming the presence of the hair.According to the visual inspection through the vision system and the infrared spectrum, the material found is a hair.The complaint reported by the customer as ¿packaging/pouch/box~foreign material in sterile package-moveable particle¿ was confirmed, a fiber was observed trapped inside the sealed and sterile pouch.According to the visual inspection through the vision system and the infrared spectrum, the material found is a hair.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ a risk assessment to address events of packaging/pouch/box-foreign material in sterile packaging has already been initiated.No further action will be taken at this time.

• Brand Name: SUPER TORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19907001
• Report Number: 9616099-2024-00255
• Device Sequence Number: 20617064
• Product Code: DQO
• UDI-Device Identifier: 10705032012676
• UDI-Public: (01)10705032012676(17)270331(10)18311140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 533552
• Device Lot Number: 18311140
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown