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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.
 
Manufacturer Narrative
The investigation of the returned balloon protector was able to confirm it as the protector which is initially mounted to protect the balloon. Further two kinks were observed at its distal end, most probably as consequence of the removal. The provided angiographic images from the initial procedure have been reviewed and did not lead to any further information regarding the nature of the complaint. Review of the manufacturing history of the product detailed above did not reveal any non-conformity. The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection. Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined. The event is related to known external factors, because the protector was not removed prior to insertion of the balloon. Please note that the instruction for use (ifu) states to: carefully remove the balloon protector by pulling on the very distal end of the protector.
 
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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
MDR Report Key7846113
MDR Text Key119255415
Report Number1028232-2018-03029
Device Sequence Number1
Product Code LIT
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,foreig
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
Device Expiration Date11/30/2020
Device Model Number366124
Device Catalogue NumberSEE MODEL NO.
Device Lot Number11175268
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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