C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; TEMPEERATURE PACING ELECTRODES
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Model Number 006173P |
Device Problems
Deflation Problem (1149); Fluid/Blood Leak (1250); Leak/Splash (1354); Defective Device (2588)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that the balloon leaked water.The device was removed and replaced to rectify the issue.The complainant noted via phone on (b)(6) 2019 that the nursing staff discovered the deflation of the balloon after removing the electrode from the patient.It was also noted that the electrode did not respond like it generally did in the body.
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Manufacturer Narrative
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The reported event was unconfirmed.A temporary pacing electrode catheter was returned.The device was inflated with 5ccs of air using a 10cc luer lock syringe.There was no leakage or bubbles when the catheter was placed underwater.The device was allowed to sit for one minute.The balloon did not deflate.The device was then deflated with no issues.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿ precautions ¿ excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.¿ when using a balloon catheter, use care when removing the protective sleeve from the distal portion of the catheter.Forced removal of this protective sleeve may result in damage to the balloon and the catheters structural integrity.¿ for non heparin bonded catheters only: when wiping down this catheter, use only sterile saline.¿ for those catheters that are heparin bonded, the following precautions apply: anticoagulant bonding: since the surface of the catheter shaft is treated with a heparin bonding, do not wipe the shaft with alcohol, its esters or ethers, or phenol compounds lest the bonding be rubbed off.If wound closure is prolonged, an appropriate topical hemostatic agent should be used to neutralize the effect of any heparin that may have been wiped off at the edge of the wound.Longer compression time at the insertion site may be required.The packaging is designed to avoid crushing of the catheter and to help protect the heparin bonding on the surface of the catheter.The heparin treated surfaces are fragile.As a result, reasonable care should be employed when removing the catheter from the package." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the balloon leaked water.The device was removed and replaced to rectify the issue.The complainant noted via phone on (b)(6) 2019 that the nursing staff discovered the deflation of the balloon after removing the electrode from the patient.It was also noted that the electrode did not respond like it generally did in the body.
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Event Description
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It was reported that the balloon leaked water.The device was removed and replaced to rectify the issue.The complainant noted via phone on (b)(6) 2019 that the nursing staff discovered the deflation of the balloon after removing the electrode from the patient.It was also noted that the electrode did not respond like it generally did in the body.
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Manufacturer Narrative
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The reported event was unconfirmed.A temporary pacing electrode catheter was returned.The device was inflated with 5ccs of air using a 10cc luer lock syringe.There was no leakage or bubbles when the catheter was placed underwater.The device was allowed to sit for one minute.The balloon did not deflate.The device was then deflated with no issues.The device was then inflated with 5ccs of water using a 10ccs luer lock syringe.There was no leakage.The device was allowed to sit for one minute.It did not deflate.The device was then deflated with no issues.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.The instructions for use were found inadequate as it does not contain instructions on whether water or air should be used in the catheter during use.The label will be updated.The instructions for use currently state the following: ¿ precautions ¿excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.¿when using a balloon catheter, use care when removing the protective sleeve from the distal portion of the catheter.Forced removal of this protective sleeve may result in damage to the balloon and the catheters structural integrity.¿for non heparin bonded catheters only: when wiping down this catheter, use only sterile saline.¿for those catheters that are heparin bonded, the following precautions apply: anticoagulant bonding: since the surface of the catheter shaft is treated with a heparin bonding, do not wipe the shaft with alcohol, its esters or ethers, or phenol compounds lest the bonding be rubbed off.If wound closure is prolonged, an appropriate topical hemostatic agent should be used to neutralize the effect of any heparin that may have been wiped off at the edge of the wound.Longer compression time at the insertion site may be required.The packaging is designed to avoid crushing of the catheter and to help protect the heparin bonding on the surface of the catheter.The heparin treated surfaces are fragile.As a result, reasonable care should be employed when removing the catheter from the package.".
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Search Alerts/Recalls
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