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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G50322
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
 
Event Description
As reported, while prepping an advance 14 lp low profile balloon catheter, it was noted that the device was not filling with contrast.An inflation device was used.It appeared there might have been a hole somewhere.The procedure was successfully completed with another device of the same type.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.No adverse effects were reported due to the alleged product malfunction.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, while prepping an advance 14 lp low profile balloon catheter, it was noted that the device was not filling with contrast.An inflation device was used.It appeared there might have been a hole somewhere.The procedure was successfully completed with another device of the same type.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.No adverse effects were reported due to the alleged product malfunction.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The device was leaking approximately 2 centimeters from the strain relief.A review of the device history record (dhr) found no related non-conformances for the reported lot.Additionally, a lot history search found no other complaints have been reported for this lot number.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred.Cook has concluded that a component failure unrelated to the design and manufacturing of the device contributed to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
No new patient or event information to report since the previous medwatch report was sent.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
Manufacturer Narrative
Corrected information: h1 = upon review of the file, it was discovered that the complaint device was leaking from a hole in the catheter shaft, not the balloon material.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.
 
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Brand Name
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Type of Device
LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12751782
MDR Text Key280176292
Report Number1820334-2021-02438
Device Sequence Number1
Product Code LIT
UDI-Device Identifier10827002503226
UDI-Public(01)10827002503226(17)240525(10)13982123
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/25/2024
Device Model NumberG50322
Device Catalogue NumberPTAX4-14-170-2.5-6
Device Lot Number13982123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received11/04/2021
Supplement Dates Manufacturer Received02/15/2022
03/02/2023
Supplement Dates FDA Received02/23/2022
03/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2021
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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