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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4400804X
Device Problems Balloon; Burst Container or Vessel ; Activation, Positioning or Separation Problem
Event Date 07/12/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, the physician used a powerflex pro pta balloon catheter (8 x 40 mm x 135 cm). The physician took the balloon past rated burst (12) to 15- atmospheres pressure (atm). The balloon shattered inside the patient which they needed to snare out. There was no reported patient injury. The device will be returned for evaluation.

 
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Brand NamePOWERFLEXPRO 8MM4CM 135
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key8862034
Report Number9616099-2019-03119
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number4400804X
Device LOT Number82154714
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 Received09/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/21/2018
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: 08/05/2019 Patient Sequence Number: 1
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