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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN; PACING ELECTRODE
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ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN; PACING ELECTRODE Back to Search Results
Catalog Number AI-07155
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event occurred in the emergency room.During insertion of the pacing catheter the balloon did not inflate.The catheter was removed.There was no reported patient death, injury or complications.There was a delay in therapy however no harm to patient.More information received: the ai-07155 was pre-tested using the syringe in the set.Upon insertion the balloon did not inflate (the balloon did not burst) another ai-07155 was inserted via the same insertion site without any problems.The patient outcome is ok.
 
Manufacturer Narrative
(b)(4).Teleflex received the reported device for analysis.The reported complaint of "balloon did not inflate" is not confirmed.The catheter balloon was successfully inflated.The device passed functional testing.The root cause of the complaint is undetermined.No further action required.
 
Event Description
It was reported that the event occurred in the emergency room.During insertion of the pacing catheter the balloon did not inflate.The catheter was removed.There was no reported patient death, injury or complications.There was a delay in therapy however no harm to patient.More information received: the ai-07155 was pre-tested using the syringe in the set.Upon insertion the balloon did not inflate (the balloon did not burst) another ai-07155 was inserted via the same insertion site without any problems.The patient outcome is ok.
 
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Brand Name
CATH PKGD: PACING 5 FR 110CM 25MM SPACIN
Type of Device
PACING ELECTRODE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6390985
MDR Text Key69759465
Report Number3010532612-2017-00005
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Reporter Country CodeCI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Catalogue NumberAI-07155
Device Lot Number16F16F0024
Other Device ID Number00801902002396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2016
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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