MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G50258
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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, an advance 18 lp low profile balloon catheter ruptured upon inflation to four atmospheres.The balloon was used to occlude flow as thrombin was injected into a pseudoaneurysm.Thrombin leaked into the fistula after the balloon ruptured.An unspecified cook balloon was used to complete the procedure.The patient did not require any additional procedures due to the occurrence.There has been no report of any adverse effects to the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.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 or Problem Description
Additional information was received 30mar2022.The complaint device was used for balloon occlusion of a left arm arteriovenous graft during injection of thrombin into a graft pseudoaneurysm.An unknown inflation device was used to inflate the balloon to eight atmospheres for less than one minute, at which point the balloon ruptured and blood was noted in the inflation device.The balloon was removed by itself after rupturing and no part of the device remained in the patient.The anatomy was not tortuous or calcified, and the balloon was not inflated within a stent.Because thrombin leaked into the graft after the balloon ruptured, a thrombectomy of the graft was performed to restore graft flow.
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, an advance 18 lp low profile balloon catheter ruptured upon inflation to four atmospheres.The balloon was used to occlude flow as thrombin was injected into a pseudoaneurysm.Thrombin leaked into the fistula after the balloon ruptured.An unspecified cook balloon was used to complete the procedure.The patient did not require any additional procedures due to the occurrence.There has been no report of any adverse effects to the patient.Additional information was received 30mar2022.The complaint device was used for balloon occlusion of a left arm arteriovenous graft during injection of thrombin into a graft pseudoaneurysm.An unknown inflation device was used to inflate the balloon to eight atmospheres for less than one minute, at which point the balloon ruptured and blood was noted in the inflation device.The balloon was removed by itself after rupturing and no part of the device remained in the patient.The anatomy was not tortuous or calcified, and the balloon was not inflated within a stent.Because thrombin leaked into the graft after the balloon ruptured, a thrombectomy of the graft was performed to restore graft flow.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 returned complaint device was also conducted.The complainant returned one advance 18 lp low profile balloon catheter too cook for investigation.Physical examination and device testing of the returned device confirmed the reported failure as the balloon was leaking from between the two balloon bonds.Cook completed a review of the device history record (dhr).The dhr for the complaint lot recorded one relevant nonconformance; the nonconforming 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 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.Cook concluded that a manufacturing/quality control deficiency was the cause of this failure mode.A capa was previously opened to investigate this issue.The capa implemented corrective actions to address these root causes after the reported lot for this complaint was manufactured.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: 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: 13904046
• Report Number: 1820334-2022-00456
• Device Sequence Number: 4303250
• Product Code: DQY
• UDI-Device Identifier: 10827002502588
• UDI-Public: (01)10827002502588(17)220524(10)9764151
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

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: 05/24/2022
• Device Model Number: G50258
• Device Catalogue Number: PTA4-18-80-7-6
• Device Lot Number: 9764151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 05/10/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/13/2022; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR TERUMO SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female