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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 6/60/90 PERIPHERAL DILATION CATHETER

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BIOTRONIK AG PASSEO-18 6/60/90 PERIPHERAL DILATION CATHETER Back to Search Results
Model Number 357467
Device Problem Burst Container or Vessel (1074)
Patient Problem Injury (2348)
Event Date 01/10/2018
Event Type  Injury  
Manufacturer Narrative
The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event. The complaint instrument was returned in two parts. The distal balloon fragment is compressed, indicating that this part of the balloon got caught during the device withdrawal. The inner shaft has fractured proximal to the proximal x-ray marker and is severely elongated, indicating that a high tensile force was present. The balloon has burst transversally and several deep scratches were found on the balloon surface near the fracture site. The review of the manufacturing history of the production lot did not reveal any nonconformity. The complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection, including both a leakage and pressure test. Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was determined. The transversal burst pattern was most likely induced by the target lesion.
 
Event Description
Ous mdr - balloon ruptured into two parts during withdrawal.
 
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Brand NamePASSEO-18 6/60/90
Type of DevicePERIPHERAL DILATION 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 Key7244458
MDR Text Key119574343
Report Number1028232-2018-00334
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
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model Number357467
Device Catalogue NumberSEE MODEL NO.
Device Lot Number11162945
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 Received04/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2016
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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