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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 6/80/130 CATHETER, ANGIOPLASTY, BALLOON DILATATION
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BIOTRONIK AG PASSEO-18 6/80/130 CATHETER, ANGIOPLASTY, BALLOON DILATATION Back to Search Results
Model Number 366124
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Claudication (2550)
Event Date 05/21/2018
Event Type  Malfunction  
Event Description

Ous mdr: it was reported that the passeo-18 balloon was used for a pta on (b)(6) 2018. On (b)(6) 2018 the patient returned to the hospital due to a short distance claudication and during examination of the vessel a foreign material was detected in the distal sfa/popliteal artery. Should additional information be provided this file will be updated.

 
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Brand NamePASSEO-18 6/80/130
Type of DeviceCATHETER, ANGIOPLASTY, BALLOON DILATATION
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 Key7846113
MDR Text Key119255415
Report Number1028232-2018-03029
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK072765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2020
Device MODEL Number366124
Device Catalogue NumberSEE MODEL NO.
Device LOT Number11175268
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/04/2017
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: 09/05/2018 Patient Sequence Number: 1
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