7003D 7003DRR

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 2019-02-11 for 7003D 7003DRR manufactured by Stryker Sustainability Solutions Phoenix.

Event Text Entries

[138665204] The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, bends were identified in the catheter shaft at 4cm, 6cm, and 7cm from the distal tip. The device inspection revealed that the catheter was unable to meet specification for curve and planarity. A kink was also identified in the catheter shaft 13cm from the distal tip. 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


[138665205] It was reported that there was a damaged electrophysiology catheter. The flexor was damaged at the time the package was opened. There was no patient injury or medical intervention. The complainant was not aware of the duration of extended procedure time. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002090040-2019-00003
MDR Report Key8326167
Report SourceHEALTH PROFESSIONAL
Date Received2019-02-11
Date of Report2019-02-11
Date of Event2018-11-15
Date Mfgr Received2019-01-17
Device Manufacturer Date2018-09-06
Date Added to Maude2019-02-11
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 Received2019-02-11
Returned To Mfg2018-12-10
Model Number7003D
Catalog Number7003DRR
Lot Number3676384
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 2019-02-11

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