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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CARDINAL HEALTH MEXICO SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51007004L
Device Problem Structural Problem (2506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information to include from section e facility name: tango central hospital, a public interest incorporated foundation concomitant device: unk sheath (6gf), unk stent. (b)(6). This device was received for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, the doctor pointed out that the position of the balloon marker of 7mm x 4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter might be out of alignment. It seems that the markers on the proximal side are placed within the interval of 4 cm. The length of the balloon shoulder on the distal side and the length of the shoulder on the proximal side appear to be clearly different. They commented that the position of the marker may have shifted at the product manufacturing stage. There was no reported patient injury. The lesion was from the right common iliac artery to superficial femoral artery with occlusion. An unknown 6gf sheath was inserted from the left brachial and inserted to the right iliac artery. After an unknown stent was implanted at the right superficial femoral artery, a saber pta was used to the right common iliac artery with moderate calcification and tortuosity and stenosed. The device was opened in sterile filed. There were no difficulty noted in the balloon during prep. There were no difficulties removing the product from the hoop, the protective balloon cover, 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. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel. There was no difficulty crossing the lesion. The catheter has never been in an acute bend. The product removed intact (in one piece) from the patient. The device will be returned for evaluation. No other information was provided.
 
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Brand NameSABER RX7MM4CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer (Section G)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer Contact
karla castro
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX   11000
7863138372
MDR Report Key11298293
MDR Text Key230949658
Report Number9616099-2021-04245
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51007004L
Device Catalogue Number51007004L
Device Lot Number82187027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2020
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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