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

Model Number	G52270
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer name and address= street: (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 angioplasty via contralateral access, an advance 35 lp low profile balloon catheter ruptured circumferentially and separated.Another manufacturer's 6 french sheath was placed in the right external iliac artery.The complaint device was used for subintimal recanalization of a long lesion within the right superficial femoral artery.The anatomy was not tortuous, but scattered calcification was noted.An inflation device was used to inflate the device to fourteen atmospheres, using a 50:50 ratio of omnipaque contrast to saline.The first and second inflations lasted two minutes each.The device was moved to different positions between inflations.Upon the third inflation of the balloon to fourteen atmospheres, the balloon ruptured.Blood was not noted in the inflation device.The balloon was not inflated within a stent.After the balloon ruptured, the user attempted to remove the device over a wire; however, the balloon catheter would not withdraw into the other manufacturer's sheath.The user attempted to pass a buddy wire to remove the device.Negative pressure was maintained with the inflation device.The user then pulled "reasonably firm¿, and the balloon catheter separated, leaving the balloon and the distal two centimeters of the balloon catheter, with the radiopaque marker, in the patient's common femoral artery.A cutdown of the groin was performed, and an embolectomy catheter was used to retrieve the separated portion of the device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, during angioplasty via contralateral access, an advance 35 lp low profile balloon catheter ruptured circumferentially and separated.Another manufacturer's 6 french sheath was placed in the right external iliac artery.The complaint device was used for subintimal recanalization of a long lesion within the right superficial femoral artery.The anatomy was not tortuous, but scattered calcification was noted.An inflation device was used to inflate the device to fourteen atmospheres, using a 50:50 ratio of omnipaque contrast to saline.The first and second inflations lasted two minutes each.The device was moved to different positions between inflations.Upon the third inflation of the balloon to fourteen atmospheres, the balloon ruptured.Blood was not noted in the inflation device.The balloon was not inflated within a stent.After the balloon ruptured, the user attempted to remove the device over a wire; however, the balloon catheter would not withdraw into the other manufacturer's sheath.The user attempted to pass a buddy wire to remove the device.Negative pressure was maintained with the inflation device.The user then pulled "reasonably firm¿, and the balloon catheter separated, leaving the balloon and the distal two centimeters of the balloon catheter, with the radiopaque marker, in the patient's common femoral artery.A cutdown of the groin was performed, and an embolectomy catheter was used to retrieve the separated portion of the device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), quality control procedures and specifications were conducted during the investigation.A visual inspection and dimensional verification of the complaint device were also conducted.Physical examination and dimensional verification of the returned device revealed evidence of elongation at approximately 82cm from the end of the strain relief and was 5cm in length.The balloon circumferentially separated and attached to the tip and the upper bond point on the proximal portion of the shaft.A small segment of the shaft measuring 4.5cm in length was separated from the tip and the proximal portion of the shaft.Cook completed a review of the device history record (dhr).The dhr for the complaint lot recorded two relevant non-conformances; both devices were scrapped, and the lot is inspected 100%.A database search for complaints reported on the complaint lot reveal no additional complaints reported at this time.Therefore, cook determined that no nonconforming product exists in house or in the field.Cook reviewed the device master record (dmr) and product labeling, including the ifu, to confirm adequate manufacturing specifications, operation parameters, and the design verification testing of the device are in place to identify and prevent this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: balloon preparation choose a balloon appropriate to lesion length and vessel diameter.Balloon introduction and inflation if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Balloon deflation and withdrawal 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.Deflate the balloon by pulling a vacuum on the inflation syringe or inflation device.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist in balloon rewrap, minimizing trauma to the percutaneous entry site.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Cook concluded that a failure to follow instructions was the primary cause of the failure.The ifu instructs the user to choose a balloon appropriate to the lesion length and vessel diameter.It is possible that the subintimal space was not large enough to accommodate the diameter of the balloon when fully inflated which most likely led to the rupture.Subsequently, when the user tried to remove the catheter and wire through the sheath with a "reasonably firm" pull, it likely caused the device to separate leaving the distal end of the device in the patient.The ifu further states, "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit,¿ and, "if resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ 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.
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: 13660474
• Report Number: 1820334-2022-00333
• Device Sequence Number: 16620863
• Product Code: DQY
• UDI-Device Identifier: 10827002522708
• UDI-Public: (01)10827002522708(17)231005(10)13468417
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 10/05/2023
• Device Model Number: G52270
• Device Catalogue Number: PTA5-35-135-6-14.0
• Device Lot Number: 13468417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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: 6 FR DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown