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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; BALLOON WEDGE PRESSURE CATHETER
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ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; BALLOON WEDGE PRESSURE CATHETER Back to Search Results
Catalog Number AI-07126
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2015
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported that while in the cath lab the wedge pressure catheter was pre-tested and it was noted at this time that it was difficult to inflate the balloon.This is the second ai-07126 (lot number 16f15h0101) in a row that after insertion they had trouble bringing the balloon back down after it was deployed in the patient.The balloon deflated after using a much larger syringe.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.There was no reported delay or interruption.The patient outcome is ok.
 
Manufacturer Narrative
Qn#(b)(4).Device evaluation: a 6fr 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 1.0cc.The 1.0cc control stroke syringe typically supplied with the kit was returned with the catheter.No moisture was observed within the inflation or injection lumen.The balloon was microscopically inspected and appeared to be typical upon initial examination.The inflation lumen was injected with 1.0cc of air using a stock 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 used a stock syringe with no issues noted.A device history record review was not performed.There was no confirmed product failure with the returned sample.Conclusion: the reported complaint that the balloon was not able to deflate is not confirmed.The catheter 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 pre-tested and it was noted at this time that it was difficult to inflate the balloon.This is the second ai-07126 (lot number 16f15h0101) in a row that after insertion they had trouble bringing the balloon back down after it was deployed in the patient.The balloon deflated after using a much larger syringe.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.There was no reported delay or interruption.The patient outcome is ok.
 
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Brand Name
CATH PKGD: WEDGE 6 FR 110 CM
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 Key5172148
MDR Text Key29210759
Report Number3010532612-2015-00028
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2017
Device Catalogue NumberAI-07126
Device Lot Number16F15H0101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received11/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2015
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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