Model Number M00545190 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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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Event Description
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It was reported to boston scientific corporation that an autotome¿ rx 39 was included in an inventory count.According to the complainant, a substance was noticed on the autotome¿ rx 39 catheter.Reportedly, there was no visible damage noted on the packaging.There were no procedure nor patient involved in this event.
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Event Description
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It was reported to boston scientific corporation that an autotome rx 39 was included in an inventory count.According to the complainant, a substance was noticed on the autotome rx 39 catheter.Reportedly, there was no visible damage noted on the packaging.There were no procedure nor patient involved in this event.
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Event Description
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It was reported to boston scientific corporation that an autotome rx 39 was included in an inventory count.According to the complainant, a substance was noticed on the autotome rx 39 catheter.Reportedly, there was no visible damage noted on the packaging.There were no procedure nor patient involved in this event.
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Manufacturer Narrative
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A visual examination of the returned device within the original pouch revealed that there was a foreign matter in the extrusion working length.No others defects were noted.The complaint is consistent with the returned device that the device has a foreign matter.Based the available/gathered information and the inspection performed to the returned product, manufacturing execution error was selected as the most probable cause, since the manufacturing process was not executed as validated/as designed as foreign matter was observed in the extrusion working length into the sealed pouch.An investigation has been initiated to address this issue.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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Search Alerts/Recalls
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