MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002530X
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.A review of the manufacturing documentation associated with this lot# 82191505 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, they noticed a hole proximal 5cm before the balloon of a 2.5mm x 30cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter.They noticed this when they were going to wet it with compression as they always do, so they did not have the unknown wire inside yet.The product was never entered inside the patient.There was no reported patient injury.The product was never used inside the patient.There was no difficulty removing the product from the hoop, from the protective balloon cover or when removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was opened in a sterile field.The user was trained with the device.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, they noticed a hole proximal 5cm before the balloon of a 2.5mm x 30cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter.They noticed this when they were going to wet it with compression as they always do, so they did not have the unknown wire inside yet.The product was never entered inside the patient.There was no reported patient injury.The product was never used inside the patient.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The device was opened in a sterile field.The user was trained with the device.The product was not returned for analysis.A product history record (phr) review of lot: 82191505 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body / shaft puncture / cut - during prep¿ was not confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely handling of the device or possible storage may have contributed to the event reported by the customer.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.According to the safety information of the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER 2.5MM30CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10697307
• Report Number: 9616099-2020-03988
• Device Sequence Number: 19626712
• Product Code: LIT
• UDI-Device Identifier: 20705032069295
• UDI-Public: 20705032069295
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 03/31/2023
• Device Model Number: 48002530X
• Device Catalogue Number: 48002530X
• Device Lot Number: 82191505
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK WIRE.; UNK WIRE