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

Model Number	G50326
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
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 procedure and using a advance 14 lp low profile balloon catheter, the balloon quickly lost pressure due to a pinhole in the balloon material.An inflation device was used.And the inflation pressure did not make it past 6atm.Inflation failed during the first attempt.A 5fr cook sheath of unknown length was also utilized during the procedure.Patient's anatomy was not noted to be tortuous or calcified.The lesion was located in the posterior tibial artery.The balloon was removed through the sheath.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 the occurrence.No adverse effects were reported due to the occurrence.
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 procedure and using a advance 14 lp low profile balloon catheter, the balloon quickly lost pressure due to a pinhole in the balloon material.An inflation device was used.And the inflation pressure did not make it past 6atm.Inflation failed during the first attempt.A 5fr cook sheath of unknown length was also utilized during the procedure.Patient's anatomy was not noted to be tortuous or calcified.The lesion was located in the posterior tibial artery.The balloon was removed through the sheath.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 the occurrence.No adverse effects were reported due to the occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angioplasty procedure and using a advance 14 lp low profile balloon catheter, the balloon quickly lost pressure due to a pinhole in the balloon material.An inflation device was used.And the inflation pressure did not make it past 6atm.Inflation failed during the first attempt.A 5fr cook sheath of unknown length was also utilized during the procedure.Patient's anatomy was not noted to be tortuous or calcified.The lesion was located in the posterior tibial artery.The balloon was removed through the sheath.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 the occurrence.No adverse effects were reported due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), quality control procedures, and specifications were conducted during the investigation.A visual inspection of the returned complaint device was also conducted.The complaint device was returned to cook for investigation.A physical examination and leak test of the returned device confirmed that the balloon leaked from near the proximal bond, but not from the bond itself.Cook completed a review of the device history record (dhr).The dhr for the reported lot found no related non-conformances.A related subassembly lot found 2 relevant non-conformances; all non-conforming products were scrapped, and the lot is inspected 100%.A review of complaint history records shows no other related complaints associated with the complaint device lot.Cook determined that no nonconforming product exists in house or in the field.Cook reviewed the device master record (dmr) and product labeling, including the ifu, to confirm adequate manufacturing specifications, operation parameters, and the design verification testing of the device are in place to identify and prevent this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: warnings do not exceed rated burst pressure.Rupture of balloon may occur.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Do not use a power injector for balloon inflation.Rupture may occur.Balloon introduction and inflation if balloon pressure is lost and / or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Balloon deflation and withdrawal if resistance is encountered during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.How supplied upon removal from package, inspect the product to ensure no damage has occurred.Cook concluded that a component failure unrelated to the design or manufacture of the compliant device caused 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.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON 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 ; 8123392235
• MDR Report Key: 13524589
• Report Number: 1820334-2022-00224
• Device Sequence Number: 5248073
• Product Code: LIT
• UDI-Device Identifier: 10827002503264
• UDI-Public: (01)10827002503264(17)231103(10)13532873
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (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): 05/05/2022

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: 11/03/2023
• Device Model Number: G50326
• Device Catalogue Number: PTAX4-14-170-2.5-20
• Device Lot Number: 13532873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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: 5FR COOK SHEATH.
• Patient Sex: Unknown