201101 201101RR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for 201101 201101RR manufactured by Stryker Sustainability Solutions Phoenix.

Event Text Entries

[146680510] The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, bends were identified 1cm and 67cm from the distal tip. The device did not meet the curve and planarity specifications. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. The most likely root cause is mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter. The instructions for use (ifu) state: - do not introduce the tip folded into the guiding sheath. - do not exert excessive pressure during placement of catheter if unknown resistance is encountered. - do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use. - avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters. \ the reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10


[146680511] It was reported that during the procedure the electrophysiology catheter did not curve properly. Instead of a c curve it looked like it was bent out of shape. The electrophysiology catheter was not deflecting enough. There was no patient injury, medical intervention, or extended procedure time reported. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002090040-2019-00014
MDR Report Key8637435
Report SourceHEALTH PROFESSIONAL
Date Received2019-05-23
Date of Report2019-05-23
Date of Event2019-04-25
Date Mfgr Received2019-04-25
Device Manufacturer Date2019-01-24
Date Added to Maude2019-05-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MARISSA RICHMOND
Manufacturer Street1810 W. DRAKE DRIVE
Manufacturer CityTEMPE AZ 85283
Manufacturer CountryUS
Manufacturer Postal85283
Manufacturer Phone8888883433
Manufacturer G1STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
Manufacturer Street10232 S. 51ST ST.
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal Code85044
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameCATHETER, RECORDING, ELECTRODE, REPROCESSED
Product CodeNLH
Date Received2019-05-23
Returned To Mfg2019-05-14
Model Number201101
Catalog Number201101RR
Lot Number3798031
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX
Manufacturer Address10232 S. 51ST ST. PHOENIX AZ 85044 US 85044


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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