MAUDE Adverse Event Report: CORDIS US CORP. SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48004010X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82232921 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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, an unknown guidewire could not pass through the guidewire lumen marked "thru" of a saber 4mmx10cm 150 percutaneous transluminal angioplasty (pta) balloon catheter.The procedure was completed after exchanging the device with another unknown product of the same size.There was no reported patient injury.The issue was noted when loading the balloon onto the guidewire to insert into the patient.There was no difficulty removing the protective balloon cover, nor was there any difficulty removing any of the sterile packaging components.Adequate flush was used/maintained throughout procedure.The access vessel was the common femoral artery (cfa).The cfa had no calcification but was a little tortuous.Stenosis was under 10%.There was no bifurcation of the vessel.The device did not kink at any time while attempting to insert onto guidewire.Other products, such as an unknown saber balloon, were successfully used with the device prior after the encountered resistance.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, an unknown guidewire could not pass through the guidewire lumen marked "thru" of a saber 4mmx10cm 150 percutaneous transluminal angioplasty (pta) balloon catheter.The procedure was completed after exchanging the device with another unknown product of the same size.There was no reported patient injury.The issue was noted when loading the balloon onto the guidewire to insert into the patient.There was no difficulty removing the protective balloon cover, nor was there any difficulty removing any of the sterile packaging components.Adequate flush was used/maintained throughout procedure.The access vessel was the common femoral artery (cfa).The cfa had no calcification but was a little tortuous.Stenosis was under 10%.There was no bifurcation of the vessel.The device did not kink at any time while attempting to insert onto guidewire.Other products, such as an unknown saber balloon, were successfully used with the device prior after the encountered resistance.The device was returned for evaluation.A non-sterile saber 5mm6cm 150 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that does not present any damages or anomalies.The balloon was received deflated.The insertion of the guidewire resulted in the identification of an obstruction in the distal tip portion.The white material noted inside the guidewire lumen was sent for ftir analysis.The results concluded the blockage is comprised of the material of polyethylene.A product history record (phr) review of lot 82232921 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen ¿ obstructed¿ was confirmed via device analysis.However, the exact cause cannot be determined.During analysis the material noted inside the guidewire lumen was noted to be polyethylene, the same material that is comprised of the guidewire lumen inner body.It is likely the accordioned piece was sheared off at some point due to the interaction of the lining with a sharp object.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.¿ the phr review does not suggest a manufacturing related issue; however, product analysis suggests that the event experienced by the customer needs further investigation to determine root cause.Therefore, an investigation has been initiated.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 18247240
• Report Number: 3007635982-2023-00338
• Device Sequence Number: 6582577
• Product Code: LIT
• UDI-Device Identifier: 20705032069479
• UDI-Public: (01)20705032069479(17)240831(10)82232921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 12/07/2023

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: 08/31/2024
• Device Catalogue Number: 48004010X
• Device Lot Number: 82232921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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 UNKNOWN PRODUCT OF THE SAME SIZE.
• Patient Sex: Unknown