MAUDE Adverse Event Report: COOK INC FORMULA 418 BILIARY BALLOON EXPANDABLE STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G42970
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: boston scientific v-18 control wire, cook 6fr flexor ansel guiding sheath.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
It was reported, during a right pulmonary artery stenting procedure, the stent of the formula 418 biliary balloon expandable stent slid off the balloon toward the device hub during insertion into the valve of a 6fr cook sheath.Access was gained via the right internal jugular vein using the cook sheath to treat a right pulmonary artery stenosis with diameter of 4.4mm and proximal normal diameter of 7.6mm.Another manufacturer's wire guide was flushed, activated, and successfully crossed the lesion.An insertion tool was used to insert the device into the sheath, and the stent was moistened with heparinized saline.After the stent slid off the balloon, the catheter was removed entirely, and a second device was used to successfully complete the procedure.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.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Corrected information: the following information was inadvertently omitted from the initial mdr: a4:weight.B5: the right pulmonary artery stenosis was reportedly the result of a previous surgical repair.The procedure was competed with another device of the same type.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 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.
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
Initial report: it was reported, during a right pulmonary artery stenting procedure, the stent of the formula 418 biliary balloon expandable stent slid off the balloon toward the device hub during insertion into the valve of a 6fr cook sheath.Access was gained via the right internal jugular vein using the cook sheath to treat a right pulmonary artery stenosis with diameter of 4.4mm and proximal normal diameter of 7.6mm.Another manufacturer's wire guide was flushed, activated, and successfully crossed the lesion.An insertion tool was used to insert the device into the sheath, and the stent was moistened with heparinized saline.After the stent slid off the balloon, the catheter was removed entirely, and a second device was used to successfully complete the procedure.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.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, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection and dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that one used device to cook for investigation.Some biomatter was present.No damage was noted to the catheter or stent.The stent¿s length and diameter were measured to be within specification.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported lot-related complaints.There were no identified gaps in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information available provides evidence to support that the device was manufactured to specification.An ifu is also provided with this device, which notes, ¿if the stent/balloon catheter does not readily advance through the stricture, do not force.If the stent will not advance in spite of good guiding catheter/introducer support, consider dilating the stricture, or changing the wire guide or the guiding catheter/introducer.¿ based on the information available, investigation has concluded that a cause is traced to a component failure without a manufacturing or design deficiency.If resistance was felt with the insertion tool, this could have caused displacement of the stent.We will continue our monitoring of similar complaints and have 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.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.

• Brand Name: FORMULA 418 BILIARY BALLOON EXPANDABLE STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9535991
• Report Number: 1820334-2019-03173
• Device Sequence Number: 3337220
• Product Code: FGE
• UDI-Device Identifier: 10827002429700
• UDI-Public: (01)10827002429700(17)210507(10)NS8864629
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: 05/07/2021
• Device Model Number: G42970
• Device Catalogue Number: FORB4-18-135-8-16
• Device Lot Number: NS8864629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 05/14/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 02/13/2020; 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 10