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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 2.5/80/130 PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG PASSEO-18 2.5/80/130 PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 357502
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2017
Event Type  Injury  
Event Description
Ous mdr - the passeo-18 balloon was inserted into the patient with the balloon protector still applied. The balloon could not be inflated. The balloon protector was snared out and fully retrieved. The patient is a (b)(6) year old male.
 
Manufacturer Narrative
The device was discarded at the hospital. Therefore no technical investigation on the subject could be performed. Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspections. The provided angiographic material was reviewed but does not provide any additional information on the complaint event. The need to remove the protective sleeve prior to use, which is quite different in material and stiffness compared to the balloon itself, is a standard procedure for balloon catheters and mentioned in the related instruction for use. Based on the conducted investigations no material or manufacturing related root cause could be determined.
 
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Brand NamePASSEO-18 2.5/80/130
Type of DevicePERIPHERAL DILATATION CATHETER
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 Key6463792
MDR Text Key71884412
Report Number1028232-2017-01199
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K072765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number357502
Device Catalogue NumberSEE MODEL NO.
Device Lot Number05165988
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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