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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION RUNWAY CATHETER, PERCUTANEOUS Back to Search Results
Model Number 8575
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: return product consisted of a runway guide catheter and loose fm. Analysis of the tip, shaft and hub included microscopic and visual inspection. Inspection found no damage to the device. The returned foreign matter (fm) was tangled together and could not be measured accurately. The fm was identified as fluorocarbon fiber, which is consistent with ptfe lining.
 
Event Description
It was reported that foreign matter was present on the device. A model 6f runway jl3. 5 guide catheter was selected for use in a percutaneous coronary intervention (pci). During the procedure, when the physician inserted the guide catheter, there was a string like a nylon coming out of the guide catheter. The physician quickly pulled the guide catheter out from the radial. The procedure was completed with a different device. No patient complications were reported and the patient was stable post procedure.
 
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Brand NameRUNWAY
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
AVAIL MEDICAL PRODUCTS INCORPO
noblestraat 10 14
oostrum lb 5807 GA
NL 5807 GA
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9929439
MDR Text Key186696623
Report Number2134265-2020-04348
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K033441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 04/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/12/2020
Device Model Number8575
Device Catalogue Number8575
Device Lot Number0060102873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2017
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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