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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)
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CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA) Back to Search Results
Catalog Number 606S155JX
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2015
Event Type  malfunction  
Event Description
It was reported by the hospital contact that during an aneurysm embolization when the physician tried to pass the microcoil (641cx0410/c11578) through the prowler select lp es microcatheter (606s155jx/15965185) it didn´t progress.They had to open another microcatheter (details unknown) and another microcoil (details unknown).The doctor mentioned that this event caused a delay in the procedure.It is unknown if a continuous flush solution was maintained through the microcatheter.It is unknown if there was any difficulty encountered when inserting the guidewire into the microcatheter.There was no resistance/kinking when inserting the microcatheter.There were no damages noted on the microcatheter.It is unknown if it was visually confirmed that the introducer was seated correctly and that the coil was coaxially entering the microcatheter.It is unknown if other coils had previously gone through the microcatheter without difficulty.The products will be returned for analysis.
 
Manufacturer Narrative
The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.This is 1 of 2 reports associated with report # 2954740-2015-00164.For section d 11.Concomitant medical products and therapy dates: microcoil (641cx0410/c11578); another microcatheter (details unknown); another microcoil (details unknown).
 
Manufacturer Narrative
It was reported by the hospital contact that during an aneurysm embolization when the physician tried to pass the microcoil (641cx0410/c11578) through the prowler select lp es microcatheter (606s155jx/15965185) it didn´t progress.They had to open another microcatheter (details unknown) and another microcoil (details unknown).The doctor mentioned that this event caused a delay in the procedure.It is unknown if a continuous flush solution was maintained through the microcatheter.It is unknown if there was any difficulty encountered when inserting the guidewire into the microcatheter.There was no resistance/kinking when inserting the microcatheter.There were no damages noted on the microcatheter.It is unknown if it was visually confirmed that the introducer was seated correctly and that the coil was co-asxilly entering the microcatheter.It is unknown if other coils had previously gone through the microcatheter without difficulty.The products will be returned for analysis.Based on the information, the event was not confirmed.The product was not returned for analysis; however procedural factors may have contributed to the event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
 
Manufacturer Narrative
It was reported by the hospital contact that during an aneurysm embolization when the physician tried to pass the microcoil (641cx0410/c11578) through the prowler select lp es microcatheter (606s155jx/15965185) it didn´t progress.They had to open another microcatheter (details unknown) and another microcoil (details unknown).The doctor mentioned that this event caused a delay in the procedure.It is unknown if a continuous flush solution was maintained through the microcatheter.It is unknown if there was any difficulty encountered when inserting the guidewire into the microcatheter.There was no resistance/kinking when inserting the microcatheter.There were no damages noted on the microcatheter.It is unknown if it was visually confirmed that the introducer was seated correctly and that the coil was co-asxilly entering the microcatheter.It is unknown if other coils had previously gone through the microcatheter without difficulty.The products will be returned for analysis.A non-sterile prowler select lpes j tip was received coiled inside of a plastic bag.The device was inspected and it was found compressed.The micro-catheter was inspected under microscope and it was found compressed.The received mc was tried to flush using a lab sample syringe but the water cannot pass through of the device, then a guide wire.014¿¿ lab sample was introduced into the received mc and it advance until it was stuck at 86cm from the proximal end, the guide wire was removed.After that the mc was cut at 68cm from the proximal end and the lab sample guide wire was inserted again; resistance friction was felt and additional force was applied on the device and then residues of dry saline solution can be observed inside of the received device.A review of the manufacturing documentation associated with this lot 15965185 presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported by the customer as ¿cbs ¿ obstructed¿ was confirmed.However the obstructed found in the micro-catheter was due to the dry saline solution.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Therefore no corrective action will be taken at this time.This is 1 of 2 reports associated with report # 2954740-2015-00164.
 
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Brand Name
PROWLER SELECT MICROCATHETERS
Type of Device
CES MICROCATHETERS (KRA)
Manufacturer (Section D)
CODMAN AND SHURTLEFF, INC
325 paramount dr
raynham MA
Manufacturer Contact
kimberly soter
14700 nw 57th court
miami lakes, FL 33014
5089777396
MDR Report Key4912517
MDR Text Key16523304
Report Number1058196-2015-00147
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K021591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,company represent
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Catalogue Number606S155JX
Device Lot Number15965185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2013
Type of Device Usage Initial
Patient Sequence Number1
Patient Age58 YR
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