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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

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VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 86700
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Event Description
It was reported that a visions pv.018 catheter was used in a therapeutic peripheral procedure in a slightly calcified distal iliac artery.During removal, the distal tip separated but remained intact to the non-philips guidewire and was stuck at the hemostatic valve of the sheath.Angio confirmed no piece of the catheter was retained in the patient.A new device was used to complete the procedure.No patient injury reported.This product problem is being submitted because the visions distal tip separated.There is a potential for harm if the malfunction were to recur.
 
Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions pv.018 catheter was not returned for evaluation, thus no returned product investigation was performed.Blocks h7 & h9: do not apply to this submission.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 an alleged death or deterioration in the state of the health of any person.
 
Manufacturer Narrative
Blocks d9 & h3: the visions catheter was returned for evaluation.Block h3: the visions catheter was returned without the distal tip, measuring approx.7-10 mm (0.7-1 cm).The returned proximal portion measured approx.135.5 cm from the luer to the separated distal end.The expected overall catheter length measurement is 135-139 cm.Block h6: the probable cause of the separation was likely damaged during removal/handling from the patient.Strain, impact, and forces associated with use can affect the integrity of the device.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 an alleged death or deterioration in the state of the health of any person.
 
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Brand Name
VISIONS PV .018 DIGITAL IVUS CATHETER
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
VOLCANO CORPORATION
3721 valley centre drive #500
san diego CA 92130
Manufacturer (Section G)
VOLCARICA S.R.L.
coyol free zone &business park
b37
alajuela
CS  
Manufacturer Contact
danielle bullock
3721 valley centre drive #500
san diego, CA 92130
858720-412
MDR Report Key18899760
MDR Text Key337746091
Report Number3008363989-2024-00012
Device Sequence Number1
Product Code OBJ
UDI-Device Identifier00184360000037
UDI-Public(01)00184360000037(11)231130(17)251130(10)0303053002
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number86700
Device Catalogue Number86700
Device Lot Number0303053002
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/13/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
COOK: 0.018 ROADRUNNER GUIDE WIRE.; COOK: 6F INTRODUCER SHEATH.
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