Catalog Number 1012276-15 |
Device Problems
Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Physical Property Issue (3008)
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Patient Problem
Intimal Dissection (1333)
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Event Date 01/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a lesion in the mid left anterior descending (lad) artery with mild tortuosity and mild calcification.A 3.5x15mm trek rx balloon dilatation catheter (bdc) protective sheath/stylet was removed without resistance.The device was prepped outside the anatomy prior to use.The contrast mix was 50/50.The trek was advanced toward the target lesion for pre-dilation of the lesion.The balloon was inflated to 12 atmospheres (atm) and held for 20 seconds.An attempt was made to deflate the balloon; however, the balloon would not deflate.Negative pressure was held for a few seconds and the trek partially deflated.The partially deflated device was removed from the lad and caused a spiral dissection to the proximal lad and left main coronary artery (lmca).The bdc became stuck in the introducer sheath and force was used to remove the bdc and the balloon separated from the catheter.The guide wire, introducer sheath and bdc were removed as a single unit from the anatomy.The patient required a drug eluting stent in the proximal portion and a bare metal stent in the lmca.There was a clinically significant delay in the procedure due to the dissection and additional stenting.There was no medication administered.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: (b)(4).Visual inspections were performed on the returned device.The reported separation and damage were confirmed.The reported deflation difficulty and resistance with the guiding catheter were not tested due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of dissection is a known observed and potential patient effect as listed in the trek rx instruction for use (ifu).Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted that the coronary dilatation catheters trek rx global instructions for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported deflation difficulty and patient effect.However the damage, difficulty removing from the protective sheath, separation and treatment appear to be related to the circumstances to the procedure.
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Event Description
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Subsequent to the previously filed medwatch, additional information indicated that the severe balloon damage was caused by a guide catheter and not by an introducer sheath.No additional information was provided.
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Search Alerts/Recalls
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