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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 4/200/90 INTERVENTIONAL
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BIOTRONIK AG PASSEO-18 4/200/90 INTERVENTIONAL Back to Search Results
Model Number 376280
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2015
Event Type  Injury  
Event Description

Ous mdr - it was determined that one lot of the passeo-18 was wrongly labeled. The passeo-18 3. 5/40/135, lot 11144151, was wrongly labelled as passeo-18 4/200/90, lot 12142151. To date, we have received one customer complaint relating to this error without any patient injury reported. The passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This voluntary field safety corrective action applies only to the passeo-18 lot mentioned in this event. Other lots are not concerned.

 
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Brand NamePASSEO-18 4/200/90
Type of DeviceINTERVENTIONAL
Manufacturer (Section D)
BIOTRONIK AG
ackerstrasse 6
buelach CH-81 80
SZ CH-8180
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key5504314
MDR Text Key40475703
Report Number1028232-2016-01091
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK151744
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number376280
Device Catalogue NumberSEE MODEL NO.
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 Received03/16/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/16/2016 Patient Sequence Number: 1
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