MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G30850
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an angioplasty an advance 18 lp low profile pta balloon dilatation catheter burst during the initial inflation when it reached 5 atm.The patient's anatomy was not noted to be calcified or tortuous at the target location.The device was inflated with an inflation device before it burst.After the device burst it was removed through a 5 fr, 110 cm cook sheath.There was blood noted in the inflation device.Another same type device was used to complete the procedure.No portion of the device was left within the patient.There was no need for additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this incident.
Additional Manufacturer Narrative
Event summary: as reported, during an angioplasty an advance 18 lp low profile pta balloon dilatation catheter burst during the initial inflation when it reached 5 atm.The patient's anatomy was not noted to be calcified or tortuous at the target location.The device was inflated with an inflation device before it burst.After the device burst it was removed through a 5 fr, 110 cm cook sheath.There was blood noted in the inflation device.Another same type device was used to complete the procedure.No portion of the device was left within the patient.There was no need for additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this incident.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), drawing, the instructions for use, specifications, and quality control data.The complainant returned one advance 18 lp low profile pta balloon dilatation catheter to cook for investigation.Physical examination and testing of the device revealed a pin hole leak was present during inflation.Cook reviewed the dhr.The dhr for the final lot records 1 relevant nonconformance for a failed leakage test in 1 device, however, the nonconforming product was scrapped, and the lot is inspected 100%.A database search for complaints reported about the complaint lot reveals no additional complaints at this time.Therefore, cook determined that no nonconforming products exist in house or in the 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: balloon introduction and inflation: ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ how supplied: ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ cook concluded that a component failure unrelated to the design or manufacturing of the complaint device caused this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
• Common Device Name: 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 ; 8128294891
• MDR Report Key: 13040402
• Report Number: 1820334-2021-02716
• Device Sequence Number: 5448937
• Product Code: LIT
• UDI-Device Identifier: 10827002308500
• UDI-Public: (01)10827002308500(17)240825(10)14170233
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2024
• Device Model Number: G30850
• Device Catalogue Number: PTAX4-18-170-5-20
• Device Lot Number: 14170233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 12/19/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 FR, 110 CM COOK SHEATH
• Patient Sex: Male