|
It is unknown if the device will be returned.Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.The product code for cook advance balloon devices is either dqy (dqy catheter, percutaneous) or lit (lit catheter, angioplasty, peripheral, transluminal).The complaint device is either a 35lp or 18lp cook balloon.Customer name and address= postal: (b)(6).Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
|
|
D10, h3: one device was returned to cook from the customer.It is unknown at this time if the returned device is associated with mdr 1820334-2020-02301 or mdr 1820334-2020-02300.The lot number of that device is 13326895 and the rpn is pta5-35-135-4-20.0.D2: although it is unknown if the complaint device that was returned is associated with mdr 1820334-2020-02301 or mdr 1820334-2020-02300, the product code for pta5-35-135-4-20.0 is lit (lit catheter, angioplasty, peripheral, transluminal).G5: although it is unknown if the complaint device that was returned is associated with mdr 1820334-2020-02301 or mdr 1820334-2020-02300, the 510(k) for pta5-35-135-4-20.0 is k132020.H6: no code available (3191) for adverse event/ intervention.See b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
|
Description of event: as reported, during a repeat celiac stent case, an unspecified cook advance balloon separated in the patient.The lesion was very calcified and it was difficult to pass through the stent.The balloon became caught on the stent and completely separated from the shaft of the device.A wire guide was in place during the attempted removal of the balloon catheter, which had been deflated.The reporter believes that the separated balloon was snared from the patient; resulting in a longer procedure time.No additional procedures were required.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one used balloon catheter with label indicating lot# 13326895 and rpn: pta5-35-135-4-20.0.The device was returned with a sticky note with both complaint numbers pr(b)(4) and pr(b)(4) on it.It is unknown which complaint the returned device is associated with.Physical examination of the returned device showed that the entire distal end containing the balloon was missing.The returned catheter in its current condition measured 113cm from the distal end of the strain relief.Biomatter was found throughout the retuned device.There was no damage to catheter shaft.There was no evidence from device failure analysis that the device was manufactured out of specification.The 18lp balloon was not returned for investigation, nor were photos of the 18lp balloon provided.The lot for the 18lp is unknown.A review of the device history record found four non-conformances related to the reported failure mode.The recorded non-conformances were for catheter damaged in bonder (qty.1), proximal bond damage (qty.7), foreign matter in proximal bond (qty.4), and distal bond too much backflow (qty.1).All the non-conforming products were dispositioned as scrap.These non-conformances could be potentially related to this failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: advance 18lp low profile pta balloon dilatation catheter: device description ¿the balloons are manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloons to prevent damage.They will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ intended use ¿the advance 18lp low profile pta balloon dilatation catheter has been designed for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ warnings ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ instructions for use balloon preparation ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ balloon deflation and withdrawal ¿completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate." "deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdrawal the catheter.Upon catheter withdrawal, a gentle counter-clockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site." "if resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ how supplied ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ advance 35lp low profile pta balloon dilatation catheter: device description ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ intended use ¿the advance 35lp low profile pta balloon dilatation catheter is indicated for percutaneous transluminal angioplasty (pta) of lesions peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ warnings ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ precautions ¿the catheter is not intended for the delivery of stents.¿ ¿all stents should be deployed in accordance with the manufacturer¿s indications and instructions for use.¿ instructions for use balloon preparation ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ balloon deflation and withdrawal ¿completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate." "deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdrawal the catheter.Upon catheter withdrawal, a gentle counter-clockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site." "if resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ how supplied ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that the procedure and patient¿s anatomy most likely contributed to this incident.As reported, the lesion was very calcified and hard to even pass through the stent.When pulling back on the stent, the balloon catheter caught on the stent and the balloon completely came apart.The complaint was confirmed based on customer testimony and investigation of the returned pta5 device.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
