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Model Number M0068318261 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a capio¿ slim was used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio carrier broke outside the patient.The procedure was completed with another capio¿ slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Manufacturer Narrative
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A visual examination of the returned capio slim revealed that the carrier was broken.The broken section of the carrier was not returned by the customer.A functional examination was not performed due to the device condition (carrier broken).A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the most probable cause for this event is design product enhancement since a modification would improve performance, function or appearance of the product.There is an investigation open to address the issue of "carrier broken.".
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Event Description
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It was reported to boston scientific corporation that a capio slim was used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio carrier broke outside the patient.The procedure was completed with another capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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