MAUDE Adverse Event Report: CORDIS CORPORATION GC 7F 078 AL 1 ST SH; CATHETER, PERCUTANEOUS

Model Number	77804500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17904809 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 7f.078 amplatz left 1 - short tip - 2 side holes (sh) vista brite tip catheter could not cross the blood vessel and was cut off during a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 7f.078 amplatz left 1 - short tip - 2 side holes (sh) vista brite tip catheter could not cross the blood vessel and was cut off during a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.A non- sterile catheter ¿gc 7f 078 al 1 st sh¿ was received for evaluation.During visual analysis, a separated condition was noted approximately 64 cm from the distal tip.Additionally, a compressed condition (approximately 3.5cm long) was observed on the distal end of the separated piece.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The separated edges were inspected with a vision system and no evidence of elongations or flared condition were noted.Both separated edges present with a diagonal path.A product history record (phr) review of lot 17904809 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The malfunction reported by the customer as ¿catheter (body/shaft) ~ tracking difficulty¿ could not be confirmed due to the nature of the complaint as these conditions cannot be properly duplicated in a laboratory environment.The complaint reported by the customer as ¿catheter (body/shaft) ~ separated - in-patient¿ was confirmed.The unit was returned in two pieces.Exact cause of this condition could not be conclusively determined during the analysis however, it appears as if the device was cut with a metallic instrument as evidenced by the diagonal cut.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, ¿if strong resistance is met during manipulation, discontinue the procedure, and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: GC 7F 078 AL 1 ST SH
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 15275579
• Report Number: 9616099-2022-05914
• Device Sequence Number: 17752186
• Product Code: DQY
• UDI-Device Identifier: 20705032021828
• UDI-Public: (01)20705032021828(17)220930(10)17904809
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K972978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/12/2022

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 Expiration Date: 09/30/2022
• Device Model Number: 77804500
• Device Catalogue Number: 77804500
• Device Lot Number: 17904809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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