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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

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CORDIS CORPORATION SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Back to Search Results
Model Number N/A
Device Problems Decrease in Pressure (1490); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt. Please note that this device is not sold in the us but it is similar to other cordis pta balloon catheters sold in the u. S. With the lit product code.
 
Event Description
A 7 mm 4 cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) while being ¿used to implant a non-cordis stent. The balloon catheter was replaced with a new saber, 6 x 150 which could inflate. There was no patient injury and the device will be returned for analysis.
 
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Brand NameSABER RX7MM4CM155
Type of DevicePERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9134085
MDR Text Key160567270
Report Number9616099-2019-03238
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,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model NumberN/A
Device Catalogue Number51007004L
Device Lot Number82168866
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2019 Patient Sequence Number: 1
Treatment
STENT (LIFESTENT, MEDICON)
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