MAUDE Adverse Event Report: CORDIS CORPORATION ACCS CATH EXTEN 100CM 1200PSI; INTRODUCER, CATHETER

Model Number	502102D
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	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18083133 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.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the tip of a 100 cm extension catheter came out from patient's vascular separated.The separation occurred when retracting the extension after using injector, the catheter extension part was caught in the hub and separated.Another unknown extension was used to complete the procedure.There was no reported patient injury.The extension catheter was used in a percutaneous transluminal coronary angioplasty (ptca) case.The intended target lesion was the right coronary artery.The device was stored, handled, and prepped per the instructions per use (ifu).The device did not kink around separation.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, "the tip" of a 100 cm extension catheter came out from patient's vascular separated.The separation occurred when retracting the extension after using injector, the catheter extension part was caught in the hub and separated.Another unknown extension was used to complete the procedure.There was no reported patient injury.The extension catheter was used in a percutaneous transluminal coronary angioplasty (ptca) case.The intended target lesion was the right coronary artery.The device was stored, handled, and prepped per the instructions per use (ifu).The device did not kink around separation.One non-sterile unit of a accs cath exten 100cm 1200psi was received for analysis.During visual analysis, a fractured/ separated condition was observed in the middle section of the insert component.Additionally, the retainer was observed detached from the accs cath exten tubing.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis presented evidence of grooves/brittleness and dents on the central section of the component and the end of the fractured/separated damage.The product was not returned for analysis.A product history record (phr) review of lot 18083133 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter extension-separated - during use¿ was confirmed.A separation was noted on the male insert of the tubing.The plastic deformations and the fatigue striations found on the insert material is commonly associated with fractures/separations caused by material tensile overload.However, the grooves/brittleness characteristic found may suggest the yield strength of the material could be lower on the fractured/separated area than on the section where the solid plastic material was noted.The exact cause of the event cannot be conclusively determined however, rapidly removing or jerking the tubing from the catheter hub may be a contributing factor.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, ¿to prevent damage, withdraw the catheter extension gently.Rapid removal or jerking may damage the extension.¿ the phr review, does not indicate the event is related to the device design or manufacturing process.However, an investigation has been opened to address the fractured/separated condition.

• Brand Name: ACCS CATH EXTEN 100CM 1200PSI
• Common Device Name: INTRODUCER, CATHETER
• 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: 15161098
• Report Number: 9616099-2022-05882
• Device Sequence Number: 5849592
• Product Code: DYB
• UDI-Device Identifier: 10705032064729
• UDI-Public: (01)10705032064729(17)241231(10)18083133
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: UNKNOWN
• 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): 09/26/2022

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: 12/31/2024
• Device Model Number: 502102D
• Device Catalogue Number: 502102D
• Device Lot Number: 18083133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANOTHER EXTENSION.
• Patient Sex: Unknown