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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/150/130; PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 6/150/130; PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 366135
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2019
Event Type  malfunction  
Event Description
Passeo-18 balloon catheters were chosen for treatment.During the same treatment it was not possible to cross the lesion with three passeo-18 balloons with different sizes.Finally a rotablader was used.
 
Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The final root cause is most likely related to the patients anatomy (severe calcification).
 
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Brand Name
PASSEO-18 6/150/130
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key8895467
MDR Text Key154408070
Report Number1028232-2019-03465
Device Sequence Number1
Product Code LIT
UDI-Device Identifier07640130414778
UDI-Public07640130414778
Combination Product (y/n)N
PMA/PMN Number
K072765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model Number366135
Device Catalogue NumberSEE MODEL NO.
Device Lot Number01193608
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/25/2019
Initial Date FDA Received08/14/2019
Supplement Dates Manufacturer Received10/10/2019
Supplement Dates FDA Received10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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