The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Device component code 3088 is related to device problem code (b)(4) for the problem of needle detachment.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a capio¿ slim device was used during an unknown procedure on (b)(6) 2017.According to the complainant, during procedure, the needle detached from the suture inside the patient.The procedure was completed with another capio¿ slim.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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