MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK 3.0MM X 40MM L=150CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4253004X
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	12/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the shaft of a 3mm x 40mm x 150cm sleek percutaneous transluminal angioplasty (pta) balloon catheter separated while inside the patient.The separated segment was removed with a snare.There was no reported patient injury.The intended procedure/target lesion was the artery of below the knee.The access site location was the femoral artery.The lesion was severely calcified and tortuous.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The product looked normal when removed from its packaging.The device was prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.An inflation device was used.The same indeflator was used successfully with other devices.The device did not have to pass through a previously placed stent.The balloon was inflated 3 times.The product was not removed intact (in one piece) from the patient as it was broken around the sheath.There were no other anomalies noted when the device was removed from the patient.The device was removed, and the procedure was finished.The device will be returned for evaluation.Pursuant to the fda code of federal regulations, cordis is an importer of this sleek percutaneous transluminal angioplasty (pta) balloon catheter, a distributed product made by clearstream technologies ltd.Therefore, cordis is required to report all complaints of deaths and serious injuries to the fda associated with this product.Please note that due to system limitations, the type of reportable event was selected.

• Brand Name: SLEEK 3.0MM X 40MM L=150CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD; enniscorthy; co. wexford ; EI
• MDR Report Key: 11313791
• Report Number: 1016427-2021-04761
• Device Sequence Number: 16322524
• Product Code: LIT
• UDI-Device Identifier: 00801741132414
• UDI-Public: 00801741132414
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2021
• Report Date (Section F): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 4253004X
• Device Catalogue Number: 4253004X
• Device Lot Number: CMEU0684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention