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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR X 4-1/8" (10 CM); INTRODUCER, CATHETER
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ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR X 4-1/8" (10 CM); INTRODUCER, CATHETER Back to Search Results
Catalog Number ASK-09903-BWS
Device Problems Connection Problem (2900); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported there is a rough transition from the dilator to the sheath and the dilator does not lock into the sheath, which allows the dilator to slide back out of the sheath during advancement.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer reported there is a rough transition from the dilator to the sheath and the dilator does not lock into the sheath, which allows the dilator to slide back out of the sheath during advancement.No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW PSI KIT: 9 FR X 4-1/8" (10 CM)
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10836481
MDR Text Key216156230
Report Number9680794-2020-00462
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K780532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue NumberASK-09903-BWS
Device Lot Number13F20B0388
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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