WITTICH NITINOL STONE BASKET WNSB-12-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for WITTICH NITINOL STONE BASKET WNSB-12-24 manufactured by Cook Inc.

Event Text Entries

[137560966] Common name: dislodger, stone, biliary. Pro code: lqr. Pma/510k #: k902944. Investigation? Evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the proximal hub (cap and adaptor) separated from the sheath material. A crease within the flare was noted, indicating the sheath material was caught between the cap and adaptor. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed the lot was released meeting all finished goods release criteria. It should be noted there was one other reported complaint for this lot number. Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established. Per the quality engineering risk assessment no further action is required. Cook will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10


[137560967] It was originally reported that the device valve separated from the catheter when the operator tried to pull the biliary stone out. No patient adverse events resulted from the malfunctioning of the device, and the complaint device was exchanged for a new device with no consequences for the patient. It was later discovered during the investigation of the returned device that it was the hub of the device which separated from the sheath material.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-00456
MDR Report Key8354629
Date Received2019-02-20
Date of Report2019-02-20
Date of Event2018-11-20
Date Mfgr Received2019-01-23
Device Manufacturer Date2017-11-10
Date Added to Maude2019-02-20
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 ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWITTICH NITINOL STONE BASKET
Product CodeLQR
Date Received2019-02-20
Returned To Mfg2018-12-07
Catalog NumberWNSB-12-24
Lot Number8366076
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-20

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