MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52362
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device will be returned.(b)(6).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 a fistuloplasty, an advance 35 lp low profile balloon catheter ruptured and separated.The distal fragment separated from the shaft of the device after the balloon ruptured.Everything was removed from the patient and the procedure continued.It is unknown how the separated portion of the device was retrieved."some" distress and blood loss was reported as well as increased use of radiation.Additional information regarding the event has been requested.
Event or Problem Description
Additional information was received 23aug2021.The complaint device will not be returned.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a fistuloplasty, an advance 35 lp low profile balloon catheter ruptured and separated.The distal fragment separated from the shaft of the device after the balloon ruptured.Everything was removed from the patient and the procedure continued.It is unknown how the separated portion of the device was retrieved."some" distress and blood loss was reported as well as increased use of radiation.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.A review of the device history record found no non-conformances related to the reported failure mode.A database search for complaints on the reported lot found an additional complaint from the field that reported balloon burst (pr334075).Due to the limited information cook has received, cook concluded that there is no objective evidence that the complaint lot was built out of specification.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.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ instructions for use balloon preparation ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ 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.¿ balloon deflation and withdrawal ¿1.Completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate.Note: balloons with large diameters and/or longer lengths may require longer deflation times.2.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdrawal the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.3.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove the 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.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook concluded that a component failure unrelated to the manufacturing or design of the device was the cause of this incident.Per the quality engineering risk assessment, no further action is warranted.Cook 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.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12072989
• Report Number: 1820334-2021-01613
• Device Sequence Number: 19686030
• Product Code: DQY
• UDI-Device Identifier: 10827002523620
• UDI-Public: (01)10827002523620(17)230313(10)13049890
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: G52362
• Device Catalogue Number: PTA5-35-80-8-10.0
• Device Lot Number: 13049890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 10/21/2021
• Initial Report FDA Received Date: 06/27/2021
• Supplement Report FDA Received Date: 08/24/2021; 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention