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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CROSSWALK CATHETER

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ASAHI INTECC CO., LTD. CROSSWALK CATHETER Back to Search Results
Model Number PSC18090A
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/26/2021
Event Type  Injury  
Event Description

While attempting to bring the crosswalk up from the pedal sheath the tip of the crosswalk got directed into a small branch and the tip got stuck and was left in the small vessel off the left tibial. It was on a v-18 wire at the time.

 
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Brand NameCROSSWALK
Type of DeviceCATHETER
Manufacturer (Section D)
ASAHI INTECC CO., LTD.
3-100 akatsuki-cho
seto, aichi 489-0 071
JA 489-0071
MDR Report Key12316472
MDR Text Key266361730
Report Number3004718255-2021-00235
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/12/2021,08/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPSC18090A
Device Catalogue NumberPSC18090A
Device LOT Number210521K46A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/12/2021
Distributor Facility Aware Date08/06/2021
Device Age3 mo
Event Location Hospital
Date Report TO Manufacturer08/12/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/12/2021 Patient Sequence Number: 1
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