MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 39 X 10 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG3910BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Physician was cannulating the iliac artery, however, when trying to place a 32mm palmaz long genesis biliary stent on.035¿ 39 x 10 x 80 opta pro percutaneous transluminal angioplasty (pta) balloon catheter; the stent slides off the balloon prior to proper placement and proper deployment/inflation.Physician was able to save the stent using various techniques.No harm was done to the patient.The product was stored as per labeling and opened in a sterile field.The access site was femoral.The lesion had little calcification.There was little vessel tortuosity.A 7f cordis brite tip sheath was used.A.035 non-cordis guidewire was used.There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The product, or any of the other devices used with it, had not been resterilized.During prep, the stent was not manipulated.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated nor partially inflated.The negative pressure was applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.Resistance was not met while advancing the device over the guidewire.There was no unusual force used at any time during the procedure.The stent delivery system passed through another stent.The difficulty required that the balloon was removed, and the physician was able to place the stent with manipulation and other wires.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: the physician was cannulating the iliac artery, however, when trying to place a 32mm palmaz long genesis biliary stent on.035¿ 39 x 10 x 80 opta pro percutaneous transluminal angioplasty (pta) balloon catheter; the stent slides off the balloon prior to proper placement and proper deployment/inflation.Physician was able to save the stent using various techniques.No harm was done to the patient.The product was stored as per labeling and opened in a sterile field.The access site was femoral.The lesion had little calcification.There was little vessel tortuosity.A 7f cordis brite tip sheath was used.An.035¿ non-cordis guidewire was used.There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The product, or any of the other devices used with it, had not been resterilized.During prep, the stent was not manipulated.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds (stent delivery system) in the catheter, the balloon was not inflated nor partially inflated.The negative pressure was applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.Resistance was not met while advancing the device over the guidewire.There was no unusual force used at any time during the procedure.The stent delivery system passed through another stent.The difficulty required that the balloon was removed, and the physician was able to place the stent with manipulation and other wires.The product was returned for analysis.One non-sterile unit of a sds.035¿ 39 x 10 x 80 opta pro percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a plastic bag.The concomitant 32mm palmaz long genesis biliary stent was not returned for evaluation.Per visual analysis, the balloon profile seems to have been previously inflated.Also, the balloon of the unit exhibited characteristic stent marks left by the stent indicating the stent was, at a certain time, properly mounted on the slalom balloon as expected.No anomalies were noted.A product history record (phr) review of lot 82178521 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent-dislodged - in patient¿ was confirmed since the sds was received for evaluation with no stent mounted on the balloon of the unit.However, due to the concomitant mentioned 32mm palmaz long genesis biliary stent was not returned for evaluation and no anomalies were observed on the received sds.035¿ 39 x 10 x 80 opta pro percutaneous transluminal angioplasty (pta) balloon catheter, the cause of the event reported by the customer could not be determined during the analysis.Per visual analysis, neither stretched conditions on the inner body of the unit nor any other anomaly was observed on the device.Also, the balloon profile seemed as have been previously inflated and the balloon of the unit exhibited characteristic stent marks left by the stent indicating the stent was, at a certain time, properly mounted on the slalom balloon as expected.According to the safety information in the instructions for use ¿the cordis palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system is indicated for palliation of malignant neoplasms in the biliary tree.The safety and effectiveness of the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system for use in the vascular system have not been established.Prior to stenting, the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system should be examined to verify functionality and integrity.Inspect the crimped stent for adherence to the balloon and centered placement in relation to the balloon marker bands.Do not reposition the stent or hand crimp.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.B.Under fluoroscopy, use the balloon marker bands and the radiopaque stent to position the stent centrally within the stricture.During positioning, verify that the stent is still centered within the balloon marker bands and has not been dislodged.¿ therefore, this is considered off label usage of the device.Neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: LONG GEN / PRO 39 X 10 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11582696
• Report Number: 9616099-2021-04368
• Device Sequence Number: 11982327
• Product Code: FGE
• UDI-Device Identifier: 20705032039830
• UDI-Public: 20705032039830
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: PG3910BPS
• Device Catalogue Number: PG3910BPS
• Device Lot Number: 82178521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention