During preparation for a thrombectomy procedure, an indigo system aspiration catheter 6 (cat6) was accidentally kinked while being removed from the packaging.The damage to the cat6 occurred prior to use and, therefore, the cat6 was not used.The procedure was completed using a new cat6.
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Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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