BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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Model Number M0067001210 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 08/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e2115 captures the reportable event of wound infection.Imdrf impact codes f23 and f2303 capture the reportable events of wound packing and antibiotic treatment.
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Event Description
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Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced wound infection and was treated with wound packing and antibiotics.In the physician's assessment the event was not related to the imager ii and 8/10 dilator sheath set but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax balloon and percutaneous access needle but was causally related to the procedure.
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