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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L TEMPORARY PACING PRODUCT

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ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L TEMPORARY PACING PRODUCT Back to Search Results
Catalog Number AI-07155-IK
Device Problem Material Rupture
Event Date 03/25/2015
Event Type  Malfunction  
Event Description

It was reported that the balloon ruptured in the patient during wire insertion. There is no patient information available at this time.

 
Manufacturer Narrative

Qn#(b)(4). Similar products sold in the usa: ai-07155-ks-510k-k960479; ai-07155-upm-510k-k945229.

 
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Brand NamePACING/PSI KIT: 5 FR/6 FR 2-L
Type of DeviceTEMPORARY PACING PRODUCT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth dr
chelmsford MA 01824
Manufacturer Contact
anne rosenberger, specialist
2400 bernville road
reading , PA 19605
6104783117
MDR Report Key4697495
Report Number3010532612-2015-00012
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device Catalogue NumberAI-07155-IK
Device LOT Number23F14G0657
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/08/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received03/25/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/15/2015 Patient Sequence Number: 1
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