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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 40 6X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SLALOM PTA .018 HP 40 6X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4396040T
Device Problem Burst Container or Vessel (1074)
Patient Problem Pain (1994)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
This device was received for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.
 
Event Description
As reported, the balloon of a. 018 6 x 4 40 slalom percutaneous transluminal angioplasty (pta) ruptured as the physician confirmed that blood builded up inside the balloon. The device was inflated at fourteen atmospheres (14 atms) for three minutes as its initial inflation. The balloon middle part was not inflated enough, so a guide wire (35) was placed next to the balloon to split the stenosis part. The complaint slalom thrill was inflated as second inflation. It was inflated at 14 atms for one and a half minutes. However, the patient complained of pain. The inflation was suspended. The device was removed from the patient. This was a shunt pta case. There was no reported patient injury. The physician requested a customer letter. The device is expected to be returned for evaluation.
 
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Brand NameSLALOM PTA .018 HP 40 6X4
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9539641
MDR Text Key199860047
Report Number9616099-2020-03449
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K003159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model Number4396040T
Device Catalogue Number4396040T
Device Lot Number17636408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2017
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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