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

Model Number	G42973
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 an interventional procedure of the left common iliac artery via left common femoral arterial access, the formula 418 biliary balloon expandable stent's balloon became stuck on the distal end of the stent.The stent was placed and as the user attempted to remove the balloon, it was noted to be stuck.The balloon was then advanced to the aorta and was inflated and deflated "a couple times", using a 50/50 ratio of omnipaque contrast and heparinized saline, and was successfully removed.The complaint device was reportedly chosen for the procedure because the user wanted to use a balloon-expandable stent.The anatomy was not tortuous; however, it was highly calcified.The "y" adapter was not used, nor was the insertion tool.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.
Event or Problem Description
Upon return and initial evaluation of the complaint device 15sep2020, the proximal fitting was separated and the catheter was elongated.Upon further investigation of the sheath returned along with the device associated with this complaint, the sheath was not separated as previously reported under mdr # 1820334-2020-01689.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D11: concomitant medical products= unspecified 6fr flexor sheath.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
Upon return of the complaint device, an unspecified cook flexor sheath was also returned and was noted to be separated.The separated sheath will be reported under patient identifier (b)(6).No other information has been received since the last report was sent.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an interventional procedure of the left common iliac artery via left common femoral arterial access, the formula 418 biliary balloon expandable stent's balloon became stuck on the distal end of the stent.The stent was placed and as the user attempted to remove the balloon, it was noted to be stuck.The balloon was then advanced to the aorta and was inflated and deflated "a couple times", using a 50/50 ratio of omnipaque contrast and heparinized saline, and was successfully removed.The complaint device was reportedly chosen for the procedure because the user wanted to use a balloon-expandable stent.The anatomy was not tortuous; however, it was highly calcified.The "y" adapter was not used, nor was the insertion tool.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one used balloon expandable stent catheter to cook for investigation.Physical examination of the returned device showed that the fitting was missing from the proximal end.Based on the condition of the separation point at the proximal end, the catheter shaft material appears to be separated.The balloon was bunched up on the distal end but not separated.The catheter material was elongated in some places.The catheter length in its current condition measured 141.2 cm in length.A review of the device history record found no non-conformances related to the reported failure mode.Because 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 that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use ¿the formula 418 stent is intended for use in palliation of malignant neoplasms in the biliary tree.The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of biliary duct access sheaths, guiding catheters / introducers and wire guides should be employed.¿ warnings ¿the safety and effectiveness of this device for use in the vascular system have not been established.¿ product recommendations.¿the formula 418 stent is used in conjunction with equipment required for a conventional biliary stent procedure, including, but not limited to, a biliary access set, sheath introducer, guiding catheter, wire guide, and inflation device.¿ guiding catheter / introducer selection.¿correct guiding catheter / introducer selection and technique are necessary for use of the stent.Ensure that the inside lumen of the guiding catheter / introducer is of sufficient size to allow unobstructed passage of the stent / balloon delivery catheter.¿ instructions for use.Balloon deflation and removal.¿1.Completely deflate the balloon by pulling negative pressure on the inflation device or a 20 ml syringe.Caution: allow enough time for the balloon to fully deflate prior to removal.¿ ¿2.Slowly withdraw the balloon catheter from the stent while maintaining negative pressure on the balloon.Maintain position of the guiding catheter / introducer to prevent stent from being drawn out of intended position.Observe under fluoroscopy to ensure that the balloon disengages from the stent.¿ how supplied.¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that the user technique, procedure, and patient¿s anatomy most likely contributed to the balloon to become stuck on the stent resulting in the damage to complaint device.As reported, during attempted removal the balloon reportedly became stuck on what appeared to be the distal end of stent.During removal, the ifu instructions the user to ¿completely deflate the balloon by pulling negative pressure on the inflation device or a 20 ml syringe¿ and cautions to user to allow enough time for the balloon to fully deflate prior to removal.¿ the ifu then instructs the user to ¿slowly withdraw the balloon catheter from the stent while maintaining negative pressure on the balloon.Maintain position of the guiding catheter / introducer to prevent stent from being drawn out of intended position.Observe under fluoroscopy to ensure that the balloon disengages from the stent.¿ additionally, the procedure involving intervention left common iliac artery, with patient anatomy that was reported to be highly calcified.The ifu warns, that ¿the safety and effectiveness of this device for use in the vascular system have not been established.¿ per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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: 10390724
• Report Number: 1820334-2020-01464
• Device Sequence Number: 16868563
• Product Code: FGE
• UDI-Device Identifier: 10827002429731
• UDI-Public: (01)10827002429731(17)230115(10)10266951
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2020

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: 01/15/2023
• Device Model Number: G42973
• Device Catalogue Number: FORB4-18-135-8-30
• Device Lot Number: 10266951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 09/15/2020; 12/03/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/15/2020; 10/14/2020; 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR 13CM COOK PERFORMER SHEATH; HYDRO ST WIRE; RCFN-6.0-18-MPIS-NT
• Patient Age: 65 YR