MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO LONG GEN / PRO 29 X 10 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2910BPX
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 82173462 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the stent of a 24mm palmaz long genesis transhepatic biliary stent on 29mm x 10mm x 135cm opta pro percutaneous transluminal angioplgasty (pta) balloon catheter came off the pta balloon in the body.The doctor deployed it in the iliac.A 32mm palmaz long genesis transhepatic biliary stent on 39 x 10 x 135cm opta pro pta balloon was used, however, the stent came off the balloon in the 8f unknown sheath.The stent and the sheath were pulled out of the patient.Another 32mm palmaz long genesis transhepatic biliary stent on 39 x 10 x 135cm opta pro pta balloon was used, however, the same issue occurred; the stent was dislodged in the sheath.Three devices were used in the same patient.There was no reported patient injury.The devices were stored as per labeling and opened in a sterile field.Three devices were used in patient.The devices were stored on a cart in the cath lab for four months.The products were stored, handled and prepped according to the instructions for use (ifu).There was no damage noticed to the devices prior to opening the package.There was no difficulty removing the devices from the sterile packaging.There were no kinks or other damages noted prior or after to inserting the products into the patient.The other devices used with the product did not kink or bend at any time.There was no part of the devices that were kinked.There was nothing unusual noted about the stent delivery system prior to use.There was no unusual force used at any time during the procedure.An attempt was made o recapture the stent.The target lesion was the iliac, with little calcification.There was little tortuosity.There was ninety percent stenosis.The devices were not used for a chronic total occlusion.The patient is currently doing fine.Only one device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections e4,g3, g6, h2, h3 and h6 have been updated accordingly.The stent of a 24mm palmaz long genesis transhepatic biliary stent on 29mm x 10mm x 135cm opta pro percutaneous transluminal angioplgasty (pta) balloon catheter came off the pta balloon in the body.The doctor deployed it in the iliac.An attempt was made to recapture the stent.The target lesion was the iliac, with little calcification.There was little tortuosity.There was ninety percent stenosis.A 32mm palmaz long genesis transhepatic biliary stent on 39 x 10 x 135cm opta pro pta balloon was used, however, the stent came off the balloon in the 8f unknown sheath.The stent and the sheath were pulled out of the patient.Another 32mm palmaz long genesis transhepatic biliary stent on 39 x 10 x 135cm opta pro pta balloon was used, however, the same issue occurred; the stent was dislodged in the sheath.Three devices were used in the same patient.There was no reported patient injury.The devices were stored as per labeling and opened in a sterile field.Three devices were used in patient.The devices were stored on a cart in the cath lab for four months.The products were stored, handled and prepped according to the instructions for use (ifu).There was no damage noticed to the devices prior to opening the package.There was no difficulty removing the devices from the sterile packaging.There were no kinks or other damages noted prior or after to inserting the products into the patient.The other devices used with the product did not kink or bend at any time.There was no part of the devices that were kinked.There was nothing unusual noted about the stent delivery system prior to use.There was no unusual force used at any time during the procedure.The devices were not used for a chronic total occlusion.The patient is currently doing fine.The following products were returned for analysis.A non-sterile 24mm palmaz long genesis transhepatic biliary stent on a 29mm x 10mm x 135cm opta pro pta balloon, and a non-sterile 32mm palmaz long genesis transhepatic biliary stent on a 39 x 10 x 135cm opta pro pta balloon, along with a non-sterile 8f cordis cannula sheath and its vessel dilator were received for analysis inside a plastic bag.Neither the mentioned 8f unknown sheath nor one of the reported stents of a 32mm palmaz long genesis transhepatic biliary stent on a 39 x 10 x 135cm opta pro pta balloon catheter was returned for evaluation.Per visual analysis of the 24mm palmaz long genesis transhepatic biliary stent on a 29mm x 10mm x 135cm opta pro pta balloon unit no anomalies were observed.The stent of the unit was received not deployed, properly mounted on the sds (stent delivery system) pta balloon.Per dimensional analysis, the length of the stent was verified per drawing palmaz genesis stent specification 00a7781 rev.8 and the measurement results were found within specifications.A product history record (phr) review of lot 82173462 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent-inaccurate placement¿ were not confirmed through analyses of the returned devices.One device was not returned for analysis, nor were procedural images provided for review.The exact cause of the events could not be determined during analysis.Based on the information available for review, vessel characteristics (a rate of stenosis of 90%) or procedural/handling factors may have contributed to the event as no anomalies were noted during analysis.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.¿ as this is not indicated for vascular use this event is considered off label usage.Neither the phr reviews nor the product analyses suggest 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.This event was reported by the initial reporter to the fda report number mw5099928 this is one of three devices involved in the reported event.The reporting reference number of the related devices are 9616099-2021-04373 and 9616099-2021-04374.

• Brand Name: LONG GEN / PRO 29 X 10 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11592025
• Report Number: 9616099-2021-04372
• Device Sequence Number: 19572248
• Product Code: FGE
• UDI-Device Identifier: 20705032039441
• UDI-Public: 20705032039441
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 06/30/2022
• Device Model Number: PG2910BPX
• Device Catalogue Number: PG2910BPX
• Device Lot Number: 82173462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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: UNK 8F SHEATH.; UNK SHEATH.