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Model Number M0063903200 |
Device Problems
Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).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 a will be filed.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the coil detached inside the patient and was successfully removed by using retrieval forceps.The sheath was also reported to be torn, and laser was reported to have been used during the procedure.The procedure was completed with another stone cone nitinol retrieval coil.There was no serious injury nor were there any adverse patient effects reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the coil detached inside the patient and was successfully removed by using retrieval forceps.The sheath was also reported to be torn, and laser was reported to have been used during the procedure.The procedure was completed with another stone cone nitinol retrieval coil.There was no serious injury nor were there any adverse patient effects reported as a result of this event.
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Manufacturer Narrative
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Initial reporter address 2 (b)(6).Device code 2907 captures the reportable event of coil detached.Mfr site address 1: industrial park j.,bermudez of cd juarez mfr site email: (b)(4).Investigation analysis a stone cone nitinol retrieval coil was returned for analysis.A visual evaluation of the returned device found that it was received open.The distal tip was detached from the device at the base of the coil.The wire appeared charred where the coil was detached.There was also a hole in the blue sheath.There was also charring on the edges of the hole in the sheath.Based on the condition of the device, it is likely that the failure mode seen was caused by laser damage.The dfu states "to minimize risk of device breakage or patient injury, do not fire laser directly on any part of the stone cone coil." based on the evidence of charring on both the sheath and the detached section of the coil it is likely that this device was damaged with direct laser firing.Therefore, the complaint investigation conclusion code for this complaint is failure to follow instructions, which indicates that problems were traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.Labeling review was performed and no anomalies were noted.
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Search Alerts/Recalls
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