ACHIEVE ELECTRICAL CABLE 990066

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for ACHIEVE ELECTRICAL CABLE 990066 manufactured by Medtronic Cryocath Lp.

Event Text Entries

[27944711] The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. This device was included in that field action. Based on the information received and without the return of the product, it could not determine this device performed as described in the field action. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[27944712] It was reported that prior to use, multiple mapping catheter electrical cables were received missing the outer box seal. It was noted that upon opening the catheters, there was a breached inner sterile package with cables that were labeled with tape. The cables were replaced and no patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[29372897]
Patient Sequence No: 1, Text Type: N, H10


[31056478] Product event summary: the achieve electrical cable was returned and analyzed. The cable was received in its original packaging box with a missing tampering seal and an opened sterile package pouch. Visual inspection of the cable showed that the device was intact with no apparent issues. It was noted that some units were observed with a hand written tag and masking tape. No performance testing was conducted with these units. Also, the units were for qualification testing and were not intended clinical use. A product hold order (pho) and a field action was initiated. In conclusion, the reported issue of the compromised and opened packaging was confirmed through testing. The cable failed the inspection due to an open box and pouch.
Patient Sequence No: 1, Text Type: N, H10


[104674719] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002648230-2015-00333
MDR Report Key5131793
Date Received2015-10-07
Date of Report2015-09-25
Date of Event2015-09-25
Date Mfgr Received2015-11-05
Device Manufacturer Date2015-06-09
Date Added to Maude2015-10-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANNE SCHILLING
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635052036
Manufacturer G1MEDTRONIC CARDIAC RHYTHM HEART FAILURE
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Removal Correction NumberCVG-16-Q2-12
Event Type3
Type of Report3

Device Details

Brand NameACHIEVE ELECTRICAL CABLE
Generic NameCABLE
Product CodeISN
Date Received2015-10-07
Returned To Mfg2015-10-09
Model Number990066
Catalog Number990066
Lot NumberU531
Device Expiration Date2017-06-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC CRYOCATH LP
Manufacturer Address16771 CHEMIN STE-MARIE KIRKLAND H9H 5H3 CA H9H 5H3


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-07

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