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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-15703
Device Problem Break (1069)
Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)
Event Date 06/18/2020
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

The doctor mentioned that the guide (swg) broke in the patient's vessel at the time he was performing the cvc placement. Intervention: two days later the spring guide wire was surgically removed in the operating room. Note: after requesting additional information from the customer and hospital the doctor confirmed that the patient passed away (died) and that the medical device did not contribute to the patient death.

 
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Brand NameARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10303901
MDR Text Key199746588
Report Number9680794-2020-00314
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodePE
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCV-15703
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/21/2020 Patient Sequence Number: 1
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