MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3.5MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003520X

Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Suspect tampering.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the body of a 3.5mm x 20cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was leaked.It was also noted that the device was used beyond expiration date.There is an over-label process in (b)(6).Only 1 product/unit were received in this condition.The affected lot was sold to the account prior to the expiration date.Per affiliate, preliminary judgment is that the previous dealer who bought this product had fabricated the english and (b)(6) labeling.Business with this previous dealer has been terminated.This product was handed over to the new dealer from the old dealer.The new dealer could not identify the fake labeling.There was no reported patient injury.The intended procedure was a superficial femoral occlusion.The leakage was noted during use.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 80%.The device was not used for a chronic total occlusion (total occlusion >3 months).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.The device was prepped normally (i.E., maintain negative pressure).Ge contrast media was used.The contrast to saline ratio was 1:1.A non-cordis inflation device was used.The same indeflator was not used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The plunger did not depress into the syringe/indeflator when trying to inflate.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The procedure was completed by changing the device with another balloon.The device will be returned for evaluation.

Manufacturer Narrative

Visual analysis: no product was received for analysis; instead, three pictures related to the reported failures were received.The first picture showed two boxes of saber product; the following information could be read as part of the labels placed in the boxes: box 1: catalogue# 48003520x, lot# 17647576, use by date# 2023-01-31, otw.018, 3.5mm, 20cm & 4f.Box 2: catalogue# 48003515x, lot# 17696581, otw.018, 3.5mm, 15cm & 4f.The second picture showed the outer label of a saber product and the following information could be read: catalogue# 48003520x, lot# 17647576, use by date# 2023-01-31.It can be observed that the expiration date printed below the bar code does not match the use by date printed as part of the outer label.The third picture showed the outer label with chinese information, the catalogue number 48003520x could be read as well as lot# 17647576 & a mexican address.The expiration date of 20/01/31 printed below of the bar code could be observed.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the body of a 3.5mm x 20cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter leaked.There was no reported patient injury.The intended procedure was a superficial femoral occlusion.The leakage was noted during use.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 80%.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, 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.The device was prepped normally (i.E., maintain negative pressure).Ge contrast media was used.The contrast to saline ratio was 1:1.A non-cordis inflation device was used.The same indeflator was not used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.The plunger did not depress into the syringe/indeflator when trying to inflate.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.The procedure was completed by changing the device with another balloon.The device was not returned for analysis.Pictures related to the reported failures were attached in the complaint file.It can be observed the expiration date printed below the bar code does not match the use by date printed as part of the outer label.It can be observed the expiration date 20/01/31 printed below the bar code.Expiration date verification for lot 17647576 was performed, the system states the product was sold on 2018/06/21 and that its expiration date was 2020/01/31.Label samples attached to the router were reviewed and the expiration date is correct according to specification.Based on this information, the used by date review shows that lot 17647576 met all quality requirements for product acceptance.The results indicate that this lot meets specified expiration date requirements.A product history record (phr) review of lot 17647576 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft- leakage¿ could not be confirmed as the device was not returned for analysis, only photos of the outer box were received.Therefore, the exact cause cannot be determined.The reported ¿packaging/pouch/box-labeling incorrect, expiration date exceeded and suspect brand protection - suspect tampering¿ were confirmed since mismatches between the printed expiration date vs the expiration date were established by the cordis system.There is an over-label process in china and only one product/unit was received in this condition.The affected lot was sold to the account prior to the expiration date.According to the warnings in the safety information in the instructions for use ¿store in a cool, dark, dry place.Do not use if inner package is opened or damaged.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.Suspected product tampering may have occurred; therefore, a risk assessment has been initiated for further investigation.

• Brand Name: SABER 3.5MM20CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11954833
• MDR Text Key: 258294867
• Report Number: 9616099-2021-04614
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069394
• UDI-Public: 20705032069394
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 48003520X
• Device Catalogue Number: 48003520X
• Device Lot Number: 17647576
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 75