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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90; PERIPHERAL DILATATION CATHETER

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BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90; PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 376281
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Event Description
A passeo-18 balloon catheter was chosen for treatment.The balloon was placed properly inside the lesion.As the balloon was inflated up to 6 bar the pressure of the balloon would slowly turn down.To keep the balloon inflated at 6 bar it was necessary to keep on giving more pressure.
 
Manufacturer Narrative
28-sep-2021 pma number was incorrect on the original submission.Corrected to k151744.The returned instrument was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed a fine jet of water emerging from the center of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole with transversal orientation about 62 mm proximal to the distal x-ray marker.At the origin of the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.
 
Manufacturer Narrative
28-sep-2021: pma number was incorrect on the original submission.Corrected to k151744.
 
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Brand Name
PASSEO-18 5/200/90
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key12540775
MDR Text Key273589194
Report Number1028232-2021-05344
Device Sequence Number1
Product Code LIT
UDI-Device Identifier07640130429888
UDI-Public07640130429888
Combination Product (y/n)N
PMA/PMN Number
K151744
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Model Number376281
Device Catalogue NumberSEE MODEL NO.
Device Lot Number01214725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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