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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER035 7MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER035 7MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48007004N
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
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. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the marker bands of a 0. 035¿ 7mm x 4cm x 80cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) lacks visibility. The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement. There was no reported patient injury. The saber was not exposed to long periods of sunlight in the receiving area. The humidity was not controlled in this room. The saber was stored there for around 2 days before it was distributed to the cath lab. The saber was not exposed to long periods of sunlight, high temperatures or increased humidity at any time prior to use in the cath lab. The balloon cover/sheath and shipping stylet were removed separately. There was no damage noted to the product¿s packaging prior to opening. There were no anomalies noted when the saber was removed from its packaging. There were no kinks noted on the device in the affected region. The intended procedure was an iliac procedure. The lesion was moderately calcified. There was no vessel tortuosity. The device was not used for a chronic total occlusion (total occlusion >3 months). The device was stored and handled per the instruction for use (ifu). There was no difficulty removing the product from the hoop. There was difficulty removing the protective balloon cover. There was no difficulty removing 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). An indeflator inflation device was used. The same indeflator was used successfully with other devices. There was resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the 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 catheter was not torqued against resistance. The catheter was not re-shaped by the user. The product was removed intact (in one piece) from the patient. All the marker bands were accounted for after removal of the device.
 
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Brand NameSABER035 7MM4CM 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key11273196
MDR Text Key231442382
Report Number9616099-2021-04229
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48007004N
Device Catalogue Number48007004N
Device Lot Number82196820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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