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Per (b)(6) endoscopy sales executive - hello dr.(b)(6), thanks again for your time yesterday.As we discussed, i¿ve included your cook rep, (b)(6) regarding the entombed metallic stent that you removed yesterday.(b)(6), can you connect with service line coordinator (b)(6), and dr.(b)(6) regarding this? thanks.Per physician - (b)(6), my specialist (b)(6) has the stent.She told me it might need to go to risk management but if they don¿t need to keep it, it would be worthwhile for you to figure out way to pick up the stent and have a look at it.It was only mildly encrusted but i think the primary issue was the proximal tail being stuck in tight infidibulum and i could not extract it the first time around (it torn down into a wire which i cut and left in situ the firs time around).After using the flex-xs2 and opening the indfidibulum up with a laser i was able to manually retract it down.I¿m glad this worked as the next step was some type of open/robotic procedure which would have been much more morbid.Per physician - no other adverse issue though patient is prone to uti and felt unwell after first procedure.6.3.1.1 did any unintended section of the device remain inside the patient¿s body? if yes, please describe.6.3.1.2 was the patient hospitalized or was there prolonged hospitalization due to this occurrence? 6.3.1.3 did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.-additional surgery to remove device fragment 6.3.1.4 did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Additional surgery to remove device fragment.6.3.1.5 has the complainant reported any adverse effects on the patient due to this occurrence? no other adverse issue though patient is prone to uti and felt unwell after first procedure.6.3.1.6 has the complainant reported that the product caused or contributed to the adverse effects? no other adverse issue though patient is prone to uti and felt unwell after first procedure.Please specify adverse effects and provide details.2.0 rpn prefix: stpv-083070-rms, rms & dpsci.2.1 general questions for all complaints: 2.1.1 are any images available for review? n/a, yes, no.2.1.2 what was the target location for the stent? 2.1.3 did anything have to be removed from the patient? n/a, yes, no.If yes, please specify: (i) what part of the body the device was removed from? (ii) what device was removed? (iii) what instrument was used to remove it? 2.1.4 please specify the storage conditions of the device at the facility, particularly those relating to light and temperature.2.1.5 why was the stent removed? n/a, exchange, other.If other, please detail why the stent was removed.2.1.6 if the stent was removed what was used to complete the procedure? 2.1.7 what was the length of the indwell time? 2.1.8 what disease mode was the physician trying to treat? 2.1.9 what type and size wire guide was used with the device? 2.1.10 did the device come with a pigtail straightener? n/a, yes, no.If yes, was the pigtail straightener used? n/a, yes, no.2.1.11 did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a, before, after.2.1.12 did the user attempt to attach the tapered end of the stent to the inserter? n/a, yes, no.2.1.13 was this device assembled outside of the body? n/a, yes, no.2.1.14 did the patient require any additional procedures as a result of this event? n/a, yes, no.2.1.15 what intervention (if any) was required? 2.1.16 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 2.1.17 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.If yes, please specify what was observed and where on the device it was observed.2.2 request the following should the complaint be regarding difficulty with the hydrophilic coating (wire guide): 2.2.1 what kinds of gloves were worn (latex or powdered)? n/a, latex, powdered 2.2.2 how was the coating activated? 2.2.3 how long was the coating activated? 2.2.4 where was the access site? 2.2.5 what is the patient's anatomy (calcified, tortuous)? n/a, calcified, tortuous, both 2.2.6 what is the patient's status or outcome? 2.2.7 did the patient require any additional procedures as a result of this event? n/a, yes, no.2.2.8 what intervention (if any) was required? 2.2.9 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 2.2.10 what other devices (cook or other mfr) were utilized in this case? 2.2.11 are there photos of the patient¿s symptoms (their feet, leg, etc.)? 2.2.12 are there videos/images of the device or procedure available? 2.2.13 are there any pathology reports? 2.2.14 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.If yes, please specify what was observed and where on the device it was observed.2.3 should the event involve metallic resonance (rms) stents, request the following: 2.3.1 was the stent stored in strong light (e.G.In a pyxis machine) or in direct sunlight? 2.3.2 was there difficulty advancing the stent to the target location? 2.3.3 how long was the stent in-dwelling? 2.3.4 what was used to remove the stent? 2.3.5 how often was the stent checked during the in-dwelling time? what method was used? 2.3.6 was the patient using calcium supplementation? 2.3.7 was force required to remove the stent? 2.3.8 was encrustation evident on the stent? 2.3.9 what is the source of the extrinsic compression? if caused by a tumor, what is the tumor type? what is the stage of the tumor?.
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Device evaluation the resonance stent set device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation n/a document review as the rpn and lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all resonance stent set devices are subject to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0020) state the following: ¿potential adverse events associated with indwelling ureteral stents include stent encrustation.¿ it should be noted the ifu states ¿the stent must not remain indwelling more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent¿.There is no sufficient evidence to suggest the user did not follow the ifu.Image review n/a impression n/a root cause review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patients anatomy, the obstructed area may contribute to the difficulty to remove the device.The evidence of encrustation suggests there is a possibility the stent indwell period exceeded 12 months leading to the resistance contributing to the difficulty removing the stent.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation are listed as a complication following the placement of the device.It should be noted that significant attempts were made to obtain additional information.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, no other adverse issue though patient is prone to uti and felt unwell after first procedure.Additional surgery required to remove device fragments.Complaints of this nature will continue to be monitored for potential emerging trends.
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