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

Model Number	G30937
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: purchasing.Device has been received by the manufacturer but investigation has not began yet.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 unspecified procedure using a advance 18 lp low profile balloon catheter, there was a hole noted in the balloon material of the device.Additional patient and event information has been requested.
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
Summary of event: as reported, during an unspecified procedure using a advance 18 lp low profile balloon catheter, there was a hole noted in the balloon material of the device.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 and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.Physical examination and device testing confirmed that an unseen pinhole leak was present when filling the device with air and submerging the balloon in water.Cook completed a review of the device history record (dhr).The dhr for the complaint lot found one relevant non-conformance on 1 device for a failed leakage test, however, the non-conforming product was scrapped and the lot is inspected 100%.A database search for complaints reported on the complaint lot revealed no additional complaints at this time.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.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.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.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.Based upon the available information, cook concluded that a component failure unrelated to the design or manufacture of the device was the cause of 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 18 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: 13952830
• Report Number: 1820334-2022-00490
• Device Sequence Number: 11808900
• Product Code: LIT
• UDI-Device Identifier: 10827002309378
• UDI-Public: (01)10827002309378(17)241020(10)14294677
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 10/20/2024
• Device Model Number: G30937
• Device Catalogue Number: PTA4-18-150-2-12
• Device Lot Number: 14294677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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
• Patient Sex: Unknown