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On (b)(6) 2016, epimed received medwatch report # mw5062461, informing epimed that (b)(4) filed a sus voluntary event report through the fda.The report stated that on (b)(6) 2016, the account placed a epimed catheter, more specifically a brevi-xl/2 radio-opaque epidural catheter, part # 155-2342, from lot # 11937015 into the epidural space for steroid infusion.It was reported that "part of the catheter was retained within the patient.The patient went home with the catheter in place and left it in for 4 days.It was pulled by the lay person on the 4th day and the tip of the catheter was retained in the patient." on (b)(4) 2016, epimed's qa analyst emailed epimed clinical sales consultant, to inform him of the complaint and have him forward the account investigative questions.That same day, epimed clinical sales consultant emailed the questions to dr.(b)(4) regarding the incident.On (b)(4) 2016, epimed's qa analyst emailed epimed clinical sales consultant, to follow up with him about whether or not the investigative questions had been answered by dr.(b)(4).Epimed sales rep replied stating, that he had not heard any response from the account and that same day forwarded the questions to dr.Lai, who was the reporting physician from the account.On (b)(4) 2016, epimed's qa analyst placed a call to the account leaving a message, but a return call was never received from the account.On (b)(4) 2016, epimed's qa analyst once again asked epimed's clinical sales consultant if he received any updates from the account, but he has not.It is suspected by both epimed's qa analyst and epimed's clinical sales consultant that the account may be refusing to answers questions.That same day, in a "good faith effort" to obtain additional information about the incident, epimed's qa analyst emailed dr.Lai, but to date, ((b)(4) 2016) epimed has not received a response from (b)(4) regarding this incident.While reviewing the fda medwatch report letter, it was discovered that the account reported the device in question as a brevi-xl/2 (catalog # 155-2342) with a sterile lot number of 11937015, however, epimed suspects that the catheter type and catalog number is inaccurate and was most likely reported in error by the account.Epimed's sterilization records indicate that, the corresponding sterile lot number 11937015 is for a brevi-kath catheter with an expiration date of september 30, 2020, which matches the information on the medwatch report.Due to finding, epimed proceeded with the brevi-kath as the device in question.The corresponding brevi-kath batch history records were reviewed, discovering no anomalies within any of the associated manufacturing documents.Epimed checked the accounts sales history and the last time the account purchased brevi-kath catheters was on (b)(4) 2015.Next, epimed reviewed the past 5 years of complaint history for the catheter in question; reviewing both the catheter complaint category as well as the skived/sheared complaint category.During review of these complaint files, there was one similar complaint (b)(4).Within this similar complaint, it was suspected that the catheter in question skived/sheared due to the physician's technique.Epimed has confidence that if the ifu pi-004 rev.Three (spring guide epidural catheter product) was adhered to, damage to the catheter may have been prevented.There was no lot number reported from the account within this complaint file; however, epimed is positive that the catheters are from separate lot numbers, due to the fact complaint (b)(4) was received on (b)(4) 2015, which is prior to the date ((b)(4) 2015) the lot in question was released for distribution.Although there was no needle reported within the medwatch report letter, epimed conducted an account sales history review for the possible needle that may have been used in conjunction with the corresponding catheter.Epimed's sales history showed that (b)(4) was sold two different lots of 16g rx coude needles (catalog # 105-1416).The first lot 12166919, was sold to the account on (b)(4) 2015.The second lot 12167053 was sold on (b)(4) 2015.The corresponding batch history records were reviewed for both of the lots of needles, discovering no anomalies within any of the associated manufacturing documents.Next, epimed reviewed the past 5 years of complaint history.During this review, the needle and catheter complaint categories were reviewed.Upon completion, there have been no similar complaints reported associated with the abovementioned needle lot numbers.The medwatch report stated that "the patient went home with the catheter in place and left it in for 4 days"; however, this information contraindicates the instructions given within the ifu pi-004 rev.3 (spring guide epidural catheter products), which state under the indications for use section, "intended for epidural anesthesia and limited to placement of 72 hours or less." secondly, the medwatch report states that the catheter "was pulled by the lay person on the 4th day", this also contraindicates the information listed within the ifu, under warnings number 4 it states, "the device is to be used by appropriately trained personnel.With the limited information provided on the medwatch report and no additional information provided from the account ((b)(4)), the root cause remains undetermined.However, epimed does not suspect that the root cause would be related to device failure, but rather improper handling techniques by the physician and/or "lay person".Epimed believes if the ifu pi-004 rev.3 (spring guide epidural catheter products) was followed, it may have prevented damage to the corresponding catheter.Regardless, epimed has opened complaint (b)(4) to document this event.The complaint file, as well as this mdr will be updated if new information is received.Lastly, epimed will continue to monitor future complaints to determine if adverse trending is occurring.Device not returned to epimed.
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On (b)(6) 2016, epimed emailed dr.(b)(6) from (b)(6).The email was epimed's 4th attempt to follow up with the account to acquire additional information about the medwatch report.That same day, on (b)(6) 2016, dr.(b)(6) returned epimed's email answering each question that was asked of him.Per dr.(b)(6) email he stated that the patient's health is improving.He stated that the procedure was completed successfully and he suspects the catheter sheared off after approximately 72hrs.Dr.(b)(6) stated that it has been determined to leave the remaining fragment of catheter within the patient, due to it being more of a risk than a benefit.There has been no permanent harm or long term harm to the patient from the reported event.The needle used in conjunction with the catheter was a 16g rx-2 coude needle, the lot number was not provided.Dr.(b)(6) did state that he drew back on the catheter "in order to "drive" the catheter to the intended location." the "layperson" involved in removing the catheter did not experience any resistance during removal of the catheter.The catheter remained in situ for a total of 100 hours.Per the answers above, it has now been confirmed that the end-user drew back on the catheter while the needle was in place.Epimed warns against this within their spring guide epidural catheter ifu (pi-004 rev.3), under warning #2 it states: do not remove catheter while needle is in place.Spring guide catheter and epidural needle must be removed together as a unit to prevent potential catheter damage.In addition, the catheter remained in the patient for 100 hours.Epimed's ifu (pi-004 rev.3) indicates that the catheter should be limited to placement of 72 hours or less.Therefore, epimed's initial belief of the root cause being associated to the physician's and/or "lay person's" improper handling techniques remain relevant.
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