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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 110CM; BALLOON WEDGE PRESSURE CATHETER
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ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 110CM; BALLOON WEDGE PRESSURE CATHETER Back to Search Results
Catalog Number AI-07124
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the cath lab the wedge pressure catheter was inserted via the patient's femoral artery.During use the user found the "hub end" was defective.As a result, the wedge pressure catheter was removed and replaced.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.There was a delay / interruption for the time frame required to replace the (b)(4).
 
Manufacturer Narrative
(b)(4).Device evaluation: a 5fr wedge pressure catheter was returned for evaluation.No damage, abnormalities, or kinks were noted to the catheter.The capacity of the balloon was noted to be 0.75cc.The syringe typically supplied with the kit was not returned with the catheter.The balloon was visually inspected and appeared to be typical upon initial examination.The hubs of the injection and inflation lumen appeared intact.No kinks were noted to the catheter body.The inflation lumen was injected with 0.75cc of air using a lab inventory syringe.The balloon was fully inflated.The balloon deflated in less than 3 seconds when the syringe was removed per specification.The balloon held inflation for at least one minute.The balloon inflated symmetrically.The injection lumen was aspirated and flushed with air.There was slight resistance during aspiration.A small spec of blood exited from the catheter's injection lumen after being flushed with water.After clearing the clot, the catheter was able to be aspirated and flushed with no resistance.A device history record review was not performed.There was no confirmed product failure with the returned sample.Other remarks: conclusion: the reported complaint that the hub was defective is not confirmed.No visual or functional issues were noted to any of the hubs on the device.The device passed functional testing.The root cause of the complaint is undetermined.
 
Event Description
It was reported that while in the cath lab the wedge pressure catheter was inserted via the patient's femoral artery.During use the user found the "hub end" was defective.As a result, the wedge pressure catheter was removed and replaced.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.There was a delay / interruption for the time frame required to replace the (b)(4).
 
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Brand Name
CATH PKGD: WEDGE 5 FR 110CM
Type of Device
BALLOON WEDGE PRESSURE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5217168
MDR Text Key30993274
Report Number3010532612-2015-00032
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2016
Device Catalogue NumberAI-07124
Device Lot Number16F14J0033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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