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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ACCESS VASCULAR, INC. HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number MID-141
Device Problem Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record for the affected lot, and its associated subassemblies was performed; this review did not reveal any anomalies, deviations, or nonconformances. Lot release testing results for the finished good lot were reviewed, and also did not reveal any anomalies or deviations; all results met the product spec requirements.
 
Event Description
The clinician reported that the hydromid catheter had occluded the day after it was implanted.
 
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Brand NameHYDROMID
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ACCESS VASCULAR, INC.
175 middlesex turnpike
suite 1a
bedford MA 01730 1459
MDR Report Key12366665
MDR Text Key269524742
Report Number3015060232-2021-00003
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model NumberMID-141
Device Catalogue NumberMID-141
Device Lot Number06072103
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2021
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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