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

Model Number G50326

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

As reported, during an unspecified procedure a advance 14 lp low profile balloon catheter broke in half.Another same type device was used to complete the procedure.No adverse effects to the patient have been reported.Additional information has been requested.

Manufacturer Narrative

Name and address: postal code: (b)(6).Initial reporter occupation: other non-healthcare professional: purchasing.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Event summary: as reported, during an unspecified procedure a advance 14 lp low profile balloon catheter broke in half.Another same type device was used to complete the procedure.No adverse effects to the patient have been reported.Investigation - evaluation.A document-based investigation was performed including a review of complaint history, device history record (dhr), drawing, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There are no complaints similar enough to this event to be used as a representative device for investigation.Cook reviewed the dhr.The dhr of the reported device lot records no nonconformance.The subassembly lot records 2 relevant nonconformance for 4 devices with shaft damage, however, all nonconforming devices were scrapped, and the lot is inspected 100%.A database search for complaints reported on the complaint lot reveals no additional complaints at this time.Therefore, cook concluded that no nonconforming product exists in house or in the field.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.Due to the limited information that could be provided, cook concluded that a component failure unrelated to the design or manufacturing of the complaint device caused this incident.Additionally, the information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.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 Description

No new patient or event information since the last report was summitted.

• 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 ; 8128294891
• MDR Report Key: 13372994
• MDR Text Key: 286363818
• Report Number: 1820334-2022-00134
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503264
• UDI-Public: (01)10827002503264(17)221008(10)10070116
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: G50326
• Device Catalogue Number: PTAX4-14-170-2.5-20
• Device Lot Number: 10070116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1