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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PERCUTAN CHOLANGIOGRAPHY SET; CATHETER, CHOLANGIOGRAPHY
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ARROW INTERNATIONAL LLC PERCUTAN CHOLANGIOGRAPHY SET; CATHETER, CHOLANGIOGRAPHY Back to Search Results
Catalog Number CS-01701
Device Problem Burst Container or Vessel (1074)
Patient Problem Insufficient Information (4580)
Event Date 06/02/2023
Event Type  malfunction  
Event Description
It was reported that "the balloon had popped with 2 sets while in surgery".The customer reported "yes" to "injuries or adverse event".At the time of this report, the customer has not returned our multiple requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3010532612-2023-00358.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "warning: do not inflate balloon beyond stated maximum inflation capacity of 0.6 cc to minimize the risk of cystic duct damage or rupture.Warning: do not use excessive pressure to inflate the balloon." 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.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "the balloon had popped with 2 sets while in surgery".The customer reported "yes" to "injuries or adverse event".At the time of this report, the customer has not returned our multiple requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3010532612-2023-00358.
 
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Brand Name
PERCUTAN CHOLANGIOGRAPHY SET
Type of Device
CATHETER, CHOLANGIOGRAPHY
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key17229047
MDR Text Key318137348
Report Number3010532612-2023-00357
Device Sequence Number1
Product Code GBZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Catalogue NumberCS-01701
Device Lot Number16F22B0048
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2022
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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