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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; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN000072
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "guide wire could not be passed through the lumen" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that "when inserting the catheter into the pulmonary vein, the guide wire could not be passed through the lumen".Therefore a new catheter was used.There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "when inserting the catheter into the pulmonary vein, the guide wire could not be passed through the lumen".Therefore a new catheter was used.There was no report of patient injury or consequence.
 
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Brand Name
CATH PKGD: WEDGE 6 FR 110 CM
Type of Device
CATHETER, FLOW DIRECTED
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 Key9330279
MDR Text Key170794382
Report Number3010532612-2019-00405
Device Sequence Number1
Product Code DYG
UDI-Device Identifier00801902002877
UDI-Public00801902002877
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Model NumberIPN000072
Device Catalogue NumberAI-07126
Device Lot Number16F19B0087
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2019
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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