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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. PACING/PSI KIT: 5 FR/6 FR 2-L TEMPORARY PACING CATHETER PRODUCTS

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ARROW INTL., INC. PACING/PSI KIT: 5 FR/6 FR 2-L TEMPORARY PACING CATHETER PRODUCTS Back to Search Results
Catalog Number AI-07155-IK
Device Problem Fluid Leak
Event Date 08/06/2014
Event Type  Malfunction  
Event Description

Reference mdr# 1036844-2014-00396 for the first event involving the same patient. It was reported that the event involved a female patient while in the cath lab during insertion of a second ai-07155-ik (lot #rf3041013). The doctor inserted the second catheter and blood was observed flowing out of the tuohy-borst lock again. As a result, the catheter was removed. A new arrow ai-07155-ik (lot #rf3041013) was used without issue. The procedure went on as planned successfully and a different doctor removed the catheter at the end of the procedure. The doctor stated there was no report of patient death, complications, injury or medical/surgical intervention requested. There was an unknown time of delay or interruption in therapy with no harm to the patient noted. The patient outcome was good. Additional information received on (b)(4) 2014 stated that they used a different insertion site for the second insertion. The delay or interruption in therapy was approximately 15 seconds. Blood did not get into the shield.

 
Manufacturer Narrative

(b)(4). Sample will not be returned for evaluation as it was discarded by the customer.

 
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Brand NamePACING/PSI KIT: 5 FR/6 FR 2-L
Type of DeviceTEMPORARY PACING CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
kathryn myers, ra
2400 bernville road
reading , PA 19605
6103780131
MDR Report Key4118839
Report Number1036844-2014-00397
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberAI-07155-IK
Device LOT NumberRF3041013
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/26/2014
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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