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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION CATH4F INF PIG 145 MOD 110CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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CORDIS CORPORATION CATH4F INF PIG 145 MOD 110CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 538453S
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
A non-sterile unit of diagnostic cath4f inf pig 145 mod 110cm product was received for analysis coiled inside a plastic bag.Part was unpacked to be visually analyzed.A kinked/bent condition was observed at 51 cm from the hub edge.No other damages or anomalies were found.Product history review could not be performed since complaint lot is unknown.Functional analysis was performed.The catheter was flushed with water prior to the evaluation.A syringe filled with water was attached to the hub and positive pressure was applied until the water flowed out of the part by the distal tip.  neither resistance nor loose material was observed during the flushing procedure.The insertion/withdrawal test was performed was inserting one.038¿ lab sample guidewire into the catheter via distal tip.The guidewire was withdrawn completely from the catheter.No obstruction was noticed, only a light resistance was felt where the kink is located.The insertion/withdrawal test was carried out successfully.The id and od of the body catheter was measured near to the kinked area and the results were verified with the ppe specification.Dimensional analysis results were found within specification.The complaint reported by the customer as ¿catheter (body/shaft) - obstructed in patient¿ was not confirmed.However, a kinked/bent condition was observed at the returned device.Exact cause of this damage could not be conclusively determined during the analysis.Dimensional analysis results were found within specification and the insertion/withdrawal test was carried out successfully and do not suggest that this damage could be related to the manufacturing process.Procedural/handling factors might have contributed to this issue.The product analysis does not suggest that the found damage could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the patient¿s blood pressure dropped to zero.The doctor removed the catheter and noticed there was a clot.The catheter was removed from the patient and flushed and continued the procedure with no further complications.
 
Event Description
As reported, the patient¿s blood pressure dropped to zero.The doctor removed the catheter and noticed there was a clot.The catheter was removed from the patient and flushed and continued the procedure with no further complications.There was no damage noted to the product packaging.There were no defects noted to the device during the procedure.The device was prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.A contralateral approach was used.There was no difficulty tracking through the vasculature.Additional procedural details were requested but are unknown.
 
Manufacturer Narrative
During an unknown procedure, the patient¿s blood pressure dropped to zero.The doctor removed the catheter and noticed there was a clot.The catheter was removed from the patient and flushed and the procedure was completed with no further complications.No patient injury was reported.There was no damage noted to the product packaging.There were no defects noted to the device during the procedure.The device was prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.A contralateral approach was used.There was no difficulty tracking through the vasculature.Additional procedural details were requested but are unknown.The device was returned for analysis.A non-sterile cath4f inf pig 145 mod 110cm was received for analysis coiled inside a plastic bag.Per visual analysis, a kinked/bent condition was noted at 51 cm from the hub edge.No other damages or anomalies were found.Per functional analysis, the catheter was flushed with water prior to the evaluation.A syringe filled with water was attached to the hub and positive pressure was applied until the water flowed out of the distal tip.Neither resistance nor loose material was observed during the flushing procedure.Per functional analysis, a.038¿ lab sample guidewire was inserted into the catheter via the distal tip, then withdrawn completely from the catheter.No obstruction was noticed, only a light resistance was felt where the kink is located.The insertion/withdrawal test was carried out successfully.Per dimensional analysis, the (inner diameter) id and (outer diameter) od of the body catheter were measured near the kinked area and the results were verified to be within the specification.Product history review could not be performed since complaint lot is unknown.The reported ¿catheter (body/shaft) - obstructed in patient¿ was not confirmed.However, a kinked/bent condition was noted.The exact cause of this damage could not be conclusively determined during the analysis.The dimensional analysis showed that the catheter met specification for inner and outer diameter, and a functional test was carried out successfully.Procedural and handling factors may have contributed to this event.Per the precautions in the instructions for use, which is not intended as a mitigation, ¿to prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ the device analysis does not indicate that the reported events could be related to the manufacturing process, therefore, no corrective or preventive actions will be taken at this time.
 
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Brand Name
CATH4F INF PIG 145 MOD 110CM
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
MDR Report Key8219403
MDR Text Key132365921
Report Number9616099-2019-02621
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K862244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number538453S
Device Catalogue Number538453S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received01/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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