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

Model Number G56611

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Common name & product code: nin; stent, renal.Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available.Occupation: non-healthcare professional.Pma/510(k) number: p100028.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

During the investigation of the events associated with patient identifiers (b)(6) (mdr 1820334-2020-00364) and (b)(6) (mdr 1820334-2020-00408) two devices were returned to cook in the same box on 26oct2020.One device from the originally reported lot 10153876 was returned, as well as one device from lot 10185395.There was no previous complaint received from the user facility associated with lot 10185395.Attempts are being made to obtain details surrounding the device from lot 10185395.Inspection of the device from lot 10185395 found that the stent was off the balloon catheter.A new complaint was opened to capture this device malfunction and is the subject of this report.It is unknown if the device was used during the case reported under 1820334-2020-00364 or 1820334-2020-00408.Both events involved stent placement within the superior vena cava.No adverse effects to the patients were reported, no additional procedures were required, and no part of the device remained in either patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: during the investigation of the events associated with patient identifiers (b)(6) (mdr 1820334-2020-00364) and 292150 (mdr 1820334-2020-00408) two devices were returned to cook in the same box on 26oct2020.One device from the originally reported lot 10153876 was returned, as well as one device from lot 10185395.There was no previous complaint received from the user facility associated with lot 10185395.Attempts are being made to obtain details surrounding the device from lot 10185395.Inspection of the device from lot 10185395 found that the stent was off the balloon catheter.A new complaint was opened to capture this device malfunction and is the subject of this report.It is unknown if the device was used during the case reported under 1820334-2020-00364 or 1820334-2020-00408.Both events involved stent placement within the superior vena cava.No adverse effects to the patients were reported, no additional procedures were required, and no part of the device remained in either patient.Investigation evaluation: reviews of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, quality control, and personnel interviews were conducted during the investigation.A visual inspection of the device was also conducted.One for418-18-80-6-12 balloon catheter was received.No visible damaged was noted to the device.The stent was present but was returned off of the balloon catheter.The crimped stent measured 12mm in length and 0.063" in diameter.Additional analysis found indentations in the balloon material, suggesting that the stent was heat set and crimped in place during the manufacturing of the device.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.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.There is no evidence that the device was manufactured out of specification.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 a definitive conclusion could not be determined.It was reported that the insertion tool was not used during insertion of the complaint device into the sheath; the user¿s practice is to simply insert the product through the sheath without the aid of a tool.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.The risk analysis for this failure mode was reviewed and no additional escalation was required.There is currently a capa investigation open to investigate this product failure.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FORMULA 418 RENAL BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10906053
• MDR Text Key: 219318377
• Report Number: 1820334-2020-02180
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002566115
• UDI-Public: (01)10827002566115(17)221203(10)10185395
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G56611
• Device Catalogue Number: FOR418-18-80-6-12
• Device Lot Number: 10185395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1