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Model Number N/A |
Device Problem
Material Separation (1562)
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Patient Problems
Thrombus (2101); Blood Loss (2597)
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Event Date 05/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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Expiration date - unknown due to unknown product code and lot number.Udi - unknown due to unknown product code and lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- unknown due to unknown product code.Device manufacture date - unknown due to unknown product code and lot number.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.
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Event Description
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Terumo medical received a letter from a law office reporting that their client was allegedly injured as a result of an unknown terumo ik sheath.On (b)(6) 2019, the patient presented to (b)(6) medical center in (b)(6) to undergo an angioplasty by the doctor, md from the (b)(6).Near the end of the procedure, a piece of the angioplasty sheath broke away from the rest of the sheath and the catheter and travelled up the blood vessel into the infrarenal aorta.The doctor was unable to visualize or remove the broken piece of sheath.Accordingly, thoracic and vascular surgeon, the doctor, md performed surgery to locate and remove the broken piece of sheath.The retained portion of the sheath was not visualized outside of the arteriotomy, so a #11 blade was used to incise the artery directly.On inspection of the incised portion of the vessel the wire was visualized but the retained portion of the sheath was not in this location.A #4 fogarty catheter was passed gently into the infrarenal aorta, inflated, and slowly withdrawn bringing with it the retained portion of the sheath as well as some thrombus.After inspection demonstrated this was the extent of the retained portion of the sheath, the guidewire was removed.The fogarty catheter was passed once again proximally and then distally into the superficial and deep femoral vessels to ensure that all associated thrombus removed.Per cardiology report: interventional report: "a 6 french ebu 3.5 guiding catheter ms advanced to the ostium of the left main.Prior to intervention aspirin, plavix and iv heparin was given to achieve an act of greater than 300 seconds.A o.Q14 inch verrata \'vire was used to cross the lesion without difficulty.Ifr was performed and was 0.96.Given his ongoing chest pain we decided to proceed with intervention.Stenting was then performed with a 3.0 x 12 mm resolute onyx drug-eluting stent times 14 atm.The initial stenosis of 70 % was reduced to 0% and timi 3 flow maintained.The plan was to put a perclose device to facilitate hemostasis.In the process of removing the sheath the sheath hub detached from the main body of the sheath and attempts were made to retrieve it with forceps.This was unsuccessful.The wire was still through the sheath.Cardiovascular surgery was called and also attempted to remove the sheath with forceps.This was unsuccessful.Decision was made to proceed with urgent vascular surgery to remove this detached sheath body.Femostop was placed and wire was left in place." "procedure in detail: after obtaining informed consent, the patient was taken to the operating room and placed in the supine position.Following the induction of adequate general endotracheal anesthesia he was prepped and draped in the usual sterile fashion.After an appropriate timeout, a skin incision made longitudinally overlying the right common femoral vessels cutting down on the previously placed wire from the cath lab.The common femoral artery and the bifurcation were dissected out and encircled proximally distally with vesseloops for vascular control.The patient was administered 5000 units of intravenous heparin and after adequate circulation time clamps were applied proximally distally.The retained portion of the sheath was not visualized outside of the arteriotomy so a #11 blade was used to incise the artery directly.On inspection of the incised portion of the vessel the wire was visualized but the retained portion of the sheath was not in this location.A #4 fogarty catheter was passed proximally gently into the infrarenal aorta, inflated, and slowly withdrawn bringing with it the retained portion of the sheatl1 a5 well a5 some thrombus.After inspection demonstrated this was the e, 1ent of the retained portion of the sheatl1, the guidewire was removed.L11e fogarty catheter \vas passed once again proximally and then distally into the superficial and deep femoral vessels to ensme all associated thrombus was removed.111e arteriotomy was then closed with a running 6-0 prolene suture starting at either end and tying in the middle.L11e vascular clamps were removed and there was a strong palpable pulse in the superficial deep femoral vessels as well as triphasic signals.'ibe patient was administered 25 mg of protamine sulfate and surgical hemostasis appeared to be excellent which point the wound was closed with running 2-0 vicryl and 4-0 monocryl suture.Sterile dressings were applied tl1e patient was x-rayed and taken to recovery room in stable condition without apparent complication.".
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Manufacturer Narrative
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This report is being submitted as follow up no.3 to provide a correction for information that was inadvertently not provided in follow up no.2.Therefore, section h10 is being updated.Although the customer confirmed that rss602 was the part number involved in the event, since the actual device was not retained, a definitive determination cannot be made, but shipping records indicate that the device may have been product code rss602 or rss603.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide a list of potential product code/lot numbers.Potential product code/ lot number combinations: 80-1060 wm31, 80-1060 wm31, rss602 wn07, 80-1060 wn07, rss603 wm10, rss602 wn07, 80-1060 wm19, rss602 wm03, 80-1060 wm26, rss603 wn14, 80-1060 wm26, 80-1060 wm26 rss602 wn07, 80-1060 wn30, rss603 wn21, 80-1060 wn28, rss602 wn28, rss602 wn28, 80-1060 wn28, rss602 wm24, 80-1060 wn02, 80-1060 wn28, rss603 xa02, 80-1060 wn08, 80-1060 wn08, rss602 wp12, rss603 xa02, 80-1060 wn14, rss602 wp12, 80-1060 wn15, 80-1060 wn15, rss603 xc13, rss602 xa09, rss603 xa02, 80-1060 wn29, rss602 xc13, rss603 xa02, rss603 xa02, 80-1060 wp12, 80-1060 wp06, rss602 xa23, 80-1060 wp06, 80-1060 wp06, 80-1060 wp13, rss602 xa30, rss603 xc13, rss603 xc13, 80-1060 xa17, rss602 xd06, rss603 xc13, 80-1060 xa23, 80-1060 wg06, 80-1060 xa30, rss603 xc13, 80-1060 xc01, 80-1060 xc01, rss602 xc13, rss602 xc13, rss602 xc13, rss602 xc13, rss603 xc13, rss603 xd06, 80-1060 xd06, rss602 xd06, rss603 xd06, rss603 wm10, 80-1060 xd06, rss603 xd06, rss602 xc13, 80-1060 xd06, 80-1060 xd06, rss602 xd13, rss603 xe10, rss603 xe10, 80-1060 xe24, 80-1060 xd13.A review of the device history record of the potential product code/lot# combinations was conducted with no findings.
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Manufacturer Narrative
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This report is being submitted as follow up no.2 to provide additional information, and to provide the completed investigation results.Confirmation of the product code was received; therefore, sections d1, d2, d4 catalog number, g5, and h4 have been updated.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The operative reports for both the catherization and the vascular surgery were reviewed for this complaint; as well as the procedural log for both procedures.It was stated that the introducer sheath was used to access the femoral artery for a coronary catherization.Upon removal of the sheath the shaft detached from the hub and travelled to the infarenal aorta.Vascular surgery was required and during the procedure a fogarty cather was inserted and inflated at the infarenal aorta, slowly withdrawn, bringing with it the sheath shaft.The complaint describes "a piece of your angioplasty sheath broke away from the rest of the sheath and the catheter and travelled up the blood vessel into the infarenal aorta." per the catherization operative report, the sheath shaft detached from the sheath hub.It is unlikely that the sheath traveled through the arteriotomy and traveled against the natural flow of the blood stream, unless another device inadvertently detached the shaft from the hub and carried it to the infarenal aorta.Without assistance from another device, the natural flow pattern of the blood stream would have caused the sheath to flow downward toward the patient's popliteal artery instead of the infarenal aorta.The procedural log shows removal of the guide catheters without issue and an angiogram to assess the femoral artery for the use of the perclose device to close the access site.The log does not mention that the sheath was seen to be detached in the angiogram.In order to perform a right femoral angiogram through a sheath left in place, the shaft must still be intact, otherwise the user is flushing through a detached hub.Neither the operative report nor the procedural log mentions what was seen in the angiogram.It's unclear how the sheath shaft was detached and there was no damage observed on the concomitant devices.While reviewing the procedural log and the operative report for the catherization, there were no complications or issues noted while removing the catheter.It cannot be confirmed if torsional and tensile forces were used to remove the sheath.There was no information given regarding possible issues with inserting the sheath or resistance felt during removal due to either spasming, calcification, or possible scar tissue at the access site.Possible resistance felt during insertion or withdrawal could have led to torsional and tensile forces being used on the device, causing the sheath shaft to separate from the hub.The chief medical officer and clinical quality specialist (post market surveillance and vigilance) were consulted for this complaint and it was determined that based on the available information the exact root cause of the event cannot be determined.The description of the sequence of events prior to the detachment of the sheath does not align with the allegation.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
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Search Alerts/Recalls
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