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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 4X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SLALOM PTA .018 HP 40 4X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4394040T
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82220387 presented no issues during the manufacturing process that can be related to the reported event. The device was not returned for analysis. A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, during the percutaneous transluminal angioplasty (pta) of a shunt, the balloon of a slalom thrill. 018 hp 40 4x4 pta balloon catheter ruptured at approximately 6 atmospheres (atm). The slalom thrill pta balloon catheter was removed, and a different size slalom thrill pta was used successfully to complete the procedure. There was no reported injury to the patient. Additional information was requested, but due to covid 19, the information was not able to be obtained and the device will not be returned.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82220387 presented no issues during the manufacturing process that can be related to the reported event. The device was not returned for analysis. A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, during the percutaneous transluminal angioplasty (pta) of a shunt, the balloon of a slalom thrill. 018 hp 40 4x4 pta balloon catheter ruptured at approximately 6 atmospheres (atm). The slalom thrill pta balloon catheter was removed, and a different size slalom thrill pta was used successfully to complete the procedure. There was no reported injury to the patient. Additional information was requested, but due to covid 19, the information was not able to be obtained and the device will not be returned.
 
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Brand NameSLALOM PTA .018 HP 40 4X4
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 Key13119031
MDR Text Key286022329
Report Number9616099-2021-05240
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4394040T
Device Lot Number82220387
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2021
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: 12/30/2021 Patient Sequence Number: 1
Treatment
SLALOM THRILL PTA BALLOON CATHETER
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