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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NYKANEN RADIOFREQUENCY WIRE KIT; RF PERFORATION PROBE

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BAYLIS MEDICAL COMPANY INC. NYKANEN RADIOFREQUENCY WIRE KIT; RF PERFORATION PROBE Back to Search Results
Model Number RFK-265
Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2022
Event Type  malfunction  
Event Description
Physician had a jr2 catheter (containing coronary wire and protrack microcathether) positioned under the atretic pulmonary valve; when the coronary wire was exchanged for nykanen.The nykanen wire was straightening out their jr2 catheter, and they no longer had a good positioning under the valve.Physician opted for stiff back end of guidewire and mechanically crossed through the valve because they could not get good positioning when using the nykanen wire.While there was no adverse event related to the use of the baylis medical device, baylis medical technologies considers a device malfunction leading to a surgical delay of greater than 15 minutes to be an fda reportable event.
 
Manufacturer Narrative
While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the procedural delay.
 
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Brand Name
NYKANEN RADIOFREQUENCY WIRE KIT
Type of Device
RF PERFORATION PROBE
Manufacturer (Section D)
BAYLIS MEDICAL COMPANY INC.
5959 trans-canada highway
montreal, quebec H4T1A 1
CA  H4T1A1
Manufacturer (Section G)
BAYLIS MEDICAL COMPANY INC.
2775 matheson blvd. east
mississauga, ontario L4W 4 P7
CA   L4W 4P7
Manufacturer Contact
meghal khakhar
2775 matheson blvd. east
mississauga, ontario L4W 4-P7
CA   L4W 4P7
MDR Report Key15810261
MDR Text Key305492350
Report Number9710452-2022-00049
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/16/2022
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 Model NumberRFK-265
Device Catalogue NumberN/A
Device Lot NumberN/A
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2022
Initial Date FDA Received11/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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