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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM10CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 6MM10CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400610S
Device Problem Burst Container or Vessel (1074)
Patient Problems Rupture (2208); Obstruction/Occlusion (2422)
Event Date 02/09/2022
Event Type  Injury  
Event Description
As reported, the balloon of a powerflex pro 6mm 10cm ruptured within nominal pressure during the second inflation attempt. The powerflex was inflated within its nominal pressure during the initial inflation. It was removed and angiography was done again. It showed the left external iliac artery which was being treated ruptured. A non-cordis stent was implanted. A non-cordis balloon catheter was used for long-inflation and hemostasis was achieved. An ipsilateral approach was made with a non-cordis sheath. The unknown guidewire crossed the lesion. There was no calcification. On the following day, there was occlusion and retreatment was done. The device will not be returned for evaluation. Additional information could not be obtained.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
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Brand NamePOWERFLEXPRO 6MM10CM 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 Key13847334
MDR Text Key287609901
Report Number9616099-2022-05475
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4400610S
Device Catalogue Number4400610S
Device Lot Number82212740
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2021
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: 03/22/2022 Patient Sequence Number: 1
Treatment
(6MM MUSTANG, BOSTON SCIENTIFIC).; (EPIC, BOSTON SCIENTIFIC).; SHEATH (PARENT, MEDIKIT).; UNK GUIDEWIRE.
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