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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

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PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 86700
Device Problem Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2020
Event Type  Injury  
Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information for identifier, age, weight, ethnicity and race have been unsuccessful to date.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.The implant or explant dates are not applicable to this device.Device evaluation: not applicable for this device.Device was not returned for analysis.Correction/removal #: do not apply to this submission.The instructions for use (ifu) cautions: do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
 
Event Description
This case was reviewed and investigated according to the manufacture¿s policy.It was reported during a planned diagnostic peripheral procedure, the manufacturers device was advanced easily over another manufacturers.018 sv-5 wire into an aortic bypass graft.At a certain point the physician was no longer able to advance or pull the manufacturers device back over the wire.It was "stuck".The sv-5 wire, as well as the distal end of the manufacturers device, broke off and traveled distally to the patient's profunda.The physician snared the broken pieces.This adverse event is being submitted because additional intervention was required to remove the manufacture's device.
 
Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block b5: additional information obtained: when reviewing the procedure log the customer realized that the 6fr manufacturers catheter device was put through a 5fr sheath which is the reason the catheter broke.The device was discarded at the customer site.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
 
Event Description
This follow-up report #1 is being submitted to correct the patient coding from the initial report, and to report additional information received.
 
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Brand Name
VISIONS PV .018 CATHETER
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
PHILIPS VOLCANO
2870 kilgore road
rancho cordova CA 95670
MDR Report Key10693198
MDR Text Key211876690
Report Number2939520-2020-00028
Device Sequence Number1
Product Code OBJ
UDI-Device Identifier00184360000037
UDI-Public(01)00184360000037(17)220331(10)0301893632(90)300004659341
Combination Product (y/n)Y
PMA/PMN Number
K150442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Model Number86700
Device Catalogue NumberK8886700
Device Lot Number0301893632
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CORDIS .018 SV-5 WIRE.
Patient Outcome(s) Required Intervention;
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