MAUDE Adverse Event Report: COOK INC FORMULA 418 RENAL BALLOON-EXPANDABLE STENT

Model Number	G56625
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Common name and product code: nin; stent, renal.Occupation: lead tech.Pma/510(k) #: p100028.It is unknown if the device will be returned.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
As reported, a formula 418 renal balloon-expandable stent detached from the balloon.The access site was the right femoral vein (rfv) and the target site was the left pulmonary artery (lpa).The balloon and stent were inserted through a 5 french cook sheath (without rotating) and upon exiting the sheath within the inferior vena cava, the user noticed that the stent was not centered on the balloon.The user then removed the balloon catheter through the sheath.However; the stent came off the balloon and became stuck in the sheath during removal.The sheath and stent were removed and replaced with a new sheath and stent to continue the procedure.The anatomy was not tortuous and the balloon was never inflated.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.
Additional Manufacturer Narrative
Additional information: d9, h3: the device will not be returned for investigation.Summary of event: as reported, a formula 418 renal balloon-expandable stent detached from the balloon.The access site was the right femoral vein (rfv) and the target site was the left pulmonary artery (lpa).The balloon and stent were inserted through a 5 french cook sheath (without rotating), over a high-torque wire, and upon exiting the sheath within the inferior vena cava, the user noticed that the stent was not centered on the balloon.The user then removed the balloon catheter through the sheath; however, the stent came off the balloon and became stuck in the sheath during removal.The sheath and stent were removed and replaced with a new sheath and stent to continue the procedure.The anatomy was not tortuous, and the balloon was never inflated.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states, ¿if using an introducer with a valve, make sure the flared end of the insertion tool (provided in the package) is loaded over the premounted stent on the balloon catheter.Pass the insertion tool loaded with the premounted stent through the introducer valve.Push the formula 418 renal balloon-expandable stent system into the body of the introducer.Slide the insertion tool proximally up the catheter shaft away from the guiding catheter/introducer.A slight contact of the stent with the introducer may be felt, but there must be no resistance." the information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that unintended user error contributed to this incident.It was reported that only a 0.018¿ wire was used for insertion of the complaint device into the sheath; however, the ifu instructs the user to use the insertion tool (provided with the device) for insertion of the stent system if an introducer with a valve is used, as in this case.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
Information was available and inadvertently omitted from the initial report.The device was inserted over a 0.018-inch high torque wire.

• Brand Name: FORMULA 418 RENAL BALLOON-EXPANDABLE STENT
• 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: 14310664
• Report Number: 1820334-2022-00690
• Device Sequence Number: 4677058
• Product Code: NIN
• UDI-Device Identifier: 10827002566252
• UDI-Public: (01)10827002566252(17)250117(10)14473656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 01/17/2025
• Device Model Number: G56625
• Device Catalogue Number: FOR418-18-135-6-12
• Device Lot Number: 14473656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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: 018 HI TORQUE FLEX T WIRE; COOK PERFORMER 5 FR X 45CM
• Patient Sex: Unknown