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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer info- phone: (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 balloon dilation, an advance 35 lp low profile balloon catheter leaked.The user inserted the balloon into the patient and inflated the device to 10 atm, but the pressure would not stabilize and kept dropping.The patient had slight vessel calcification.After removing the balloon from the patient and testing the device, it was found that there was a fluid leak from the balloon.The procedure was completed with another device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a balloon dilation, an advance 35 lp low profile balloon catheter leaked.The user inserted the balloon into the patient and inflated the device to 10 atm, but the pressure would not stabilize and kept dropping.The patient had slight vessel calcification.After removing the balloon from the patient and testing the device, it was found that there was a fluid leak from the balloon.The procedure was completed with another device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.One advance 35lp low profile balloon catheter was returned to cook for investigation.Physical examination and testing of the returned device revealed that when inflated with water, bubbles and leaking occurred near the bond from the distal end of the hub.A document-based investigation evaluation was performed.Nonconformances relevant to the reported failure mode were recorded; all affected devices were scrapped and not replaced.There have been no other reported complaints for this lot number.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The device is provided instructions for use which provide the following information related to the reported failure mode: 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.¿ based on the available information, cook has concluded that this event can be attributed to a manufacturing and quality control deficiency.A capa was previously opened to investigate this issue, and actions were implemented to address these deficiencies after the product lot was manufactured.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• 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: 12323805
• Report Number: 1820334-2021-01994
• Device Sequence Number: 4136213
• Product Code: DQY
• UDI-Device Identifier: 10827002523323
• UDI-Public: (01)10827002523323(17)220625(10)9833985
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 06/25/2022
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-4-4.0
• Device Lot Number: 9833985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 61 KG