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	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hold for tg 10.14 as reported, the plastic tube of two 100 cm extension catheters which is inside the metal part was separated during the connection to another device, the retainer tubing separated in two extension catheters.The extension tubing broke when it was initially used.The procedure was completed with a third extension catheter.There was no reported patient injury.The extension catheter was stored, handled, and prepped by the instructions for use (ifu).The intended target lesion was the descending aorta.The extension catheter was used in a transcatheter aortic valve implantation (tavi) case.A non-cordis power injector was used, and psi was 900.The device was not kinked around separation.The devices were discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18076420 presented no issues during the manufacturing process that can be related to the reported event.Complaint conclusion: as reported, the plastic tube of two 100 cm extension catheters which is inside the metal part was separated during the connection to another device, the retainer tubing separated in two extension catheters.The extension tubing broke when it was initially used.The procedure was completed with a third extension catheter.There was no reported patient injury.The extension catheter was stored, handled, and prepped by the instructions for use (ifu).The intended target lesion was the descending aorta.The extension catheter was used in a transcatheter aortic valve implantation (tavi) case.A non-cordis power injector was used, and psi was 900.The device was not kinked around separation.The products, of the same lot number, were not returned for analysis.A product history record (phr) review of lot 18076420 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the devices or images for analysis, the reported customer event ¿catheter extension-separated¿ could not be confirmed.Handling factors such as excessive pulling or twisting of the extension tubing may have contributed to the reported event.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, ¿exposure to temperatures above 54°c (130°f) may damage the catheter extension.To prevent damage, withdraw the catheter extension gently.Rapid removal or jerking may damage the extension.¿ 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: 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: 15546576
• Report Number: 9616099-2022-06042
• Device Sequence Number: 14918302
• Product Code: DYB
• UDI-Device Identifier: 10705032064729
• UDI-Public: (01)10705032064729(17)241231(10)18076420
• 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
• Report Date (Section B): 10/05/2022

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: 18076420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/05/2022
• Date Device Manufactured: 01/06/2022
• 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: ASCIST CVI POWER INJECTOR; EXTENSION CATHETER
• Patient Sex: Unknown