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

Catalog Number	534622T
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	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 6f judkins left 5 infiniti diagnostic catheter broke off at the proximal bend upon inserting into a non-cordis sheath.There was no reported patient injury.The device separated in patient.The device was pulled into the sheath and separated once in sheath.The sheath was removed with the piece intact.The patient recently had an endovascular aneurysm repair (evar) and the operator of the device believes the stent-graft may have not been fully endothelialized, which could have caused a cut on the catheter that caused it to break.The product was stored properly and prepped according to the instructions for use (ifu).There were no other damages noted prior to inserting the product the product into the patient.A contralateral approach was not used.The device was pulled from the packaging by the hub and shaft of catheter.The vessel was not engaged due to the issue experienced.The device was not used for a chronic total occlusion (cto).The catheter did not become entrapped at any point in the procedure.Excessive torquing was not required.The device did not kink in the area of separation.The procedure ended because of catheter separation.There was no injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18162278 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f judkins left 5 infiniti diagnostic catheter broke off at the proximal bend upon inserting into a non-cordis sheath.There was no reported patient injury.The device separated in patient.The device was pulled into the sheath and separated once in sheath.The sheath was removed with the piece intact.The patient recently had an endovascular aneurysm repair (evar) and the operator of the device believes the stent-graft may have not been fully endothelialized, which could have caused a cut on the catheter that caused it to break.The product was stored properly and prepped according to the instructions for use (ifu).There were no other damages noted prior to inserting the product the product into the patient.A contralateral approach was not used.The device was pulled from the packaging by the hub and shaft of catheter.The vessel was not engaged due to the issue experienced.The device was not used for a chronic total occlusion (cto).The catheter did not become entrapped at any point in the procedure.Excessive torquing was not required.The device did not kink in the area of separation.The procedure ended because of catheter separation.There was no injury to the patient.The complaint device is not being returned due to their risk evaluation process, however, two unopened 6f judkins left 5 infiniti diagnostic catheters of the same lot as the complaint product are being returned for evaluation.
Additional Manufacturer Narrative
A 6f judkins left 5 infiniti diagnostic catheter broke off at the proximal bend upon inserting into a non-cordis sheath.There was no reported patient injury.The device separated in the patient.The device was pulled into the sheath and separated once in sheath.The sheath was removed with the piece intact.The patient recently had an endovascular aneurysm repair (evar) and the operator of the device believes the stent-graft may have not been fully endothelialized, which could have caused a cut on the catheter that caused it to break.The product was stored properly and prepped according to the instructions for use (ifu).There were no other damages noted prior to inserting the product the product into the patient.A contralateral approach was not used.The device was pulled from the packaging by the hub and shaft of catheter.The vessel was not engaged due to the issue experienced.The device was not used for a chronic total occlusion (cto).The catheter did not become entrapped at any point in the procedure.Excessive torquing was not required.The device did not kink in the area of separation.The procedure ended because of catheter separation.There was no injury to the patient.The complaint device is not being returned due to their risk evaluation process, however, two unopened 6f judkins left 5 infiniti diagnostic catheters of the same lot as the complaint product are being returned for evaluation.The product was not returned for analysis.However, three pictures of a cath f6inf tl jl 5 100cm were attached to the event to be evaluated.During the picture inspection, a separated condition was noted at the tip, near the fusion line.No other anomalies were noted on the images attached to the event.A product history record (phr) review of lot 18162278 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event, such as a cut on the catheter due to a not fully endothelialized stent-graft.According to the safety information in the instructions for use, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the phr review nor the product images provided 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.A risk assessment has been opened to further investigate this issue.

• Brand Name: INFINITI
• 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.; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14021 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16928420
• Report Number: 9616099-2023-06492
• Device Sequence Number: 6931085
• Product Code: DQO
• UDI-Device Identifier: 10705032014205
• UDI-Public: (01)10705032014205(17)251031(10)18162278
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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): 08/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 534622T
• Device Lot Number: 18162278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 08/05/2023
• Initial Report FDA Received Date: 05/14/2023
• Supplement Report FDA Received Date: 06/26/2023; 08/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO SHEATH
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG