MAUDE Adverse Event Report: CORDIS CASHEL LONG GEN / PRO 29 X 70 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2970BPX
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown balloon catheter omnipaque indeflator complaint conclusion: a palmaz genesis long pro 29 x 70 mm biliary 125 cm endovascular balloon-expandable stent delivery system (sds) became dislodged from the balloon and was unable to be recovered.There was no reported patient injury.The stent was deployed in the patient¿s radial artery, not the desired destination.There was resistance/friction while inserting the balloon through the guide catheter, the guide was removed and they went bare back on the wire.The catheter was never in an acute bend.The stent was deployed in the radial artery, it was not fully inflated, and was not needed in this location but could not be removed from the patient without harm.The stent was stored and prepped according to the instructions for use (ifu).The target lesion was in the right renal artery.There was a little vessel tortuosity.There was moderate vessel angulation.The device was not being used to treat chronic total occlusion (cto).The product looked normal when it was removed from the packaging.There was not any difficulty removing the product from the hoop.There was not any difficulty removing the protective balloon cover.There was not any difficulty removing the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.There was 100% contrast used for road-mapping.The indeflator was used successfully with other devices.The product was not returned for analysis.A product history record (phr) review of lot 82167584 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¿ and ¿stent inaccurate placement¿ could not be confirmed as the device was not returned for analysis, nor was procedural imagery provided for review.The exact cause could not be determined.Vessel characteristics of a little vessel tortuosity and moderate vessel angulation may have contributed to the reported event.The practice of delivering a stent without use of a guide catheter is not recommended within the vascular system.The product is not indicated for vascular usage therefore this is considered off-label use.According to the safety information in the instructions for use, ¿indications the cordis palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system is indicated for palliation of malignant neoplasms in the biliary tree.Warnings 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.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.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, a palmaz genesis long pro 29 x 70 bil 125 endovascular balloon-expandable stent (sds) became dislodged from the balloon and was unable to be recovered.There was no reported patient injury.The stent was deployed in the patient¿s radial artery, not the desired destination.The stent was stored and prepped according to the instructions for use (ifu).The target lesion was in the right renal artery.There was a little vessel tortuosity.There was moderate vessel angulation.The device was not being used to treat chronic total occlusion (cto).The product looked normal when it was removed from the packaging.There was not any difficulty removing the product from the hoop.There was not any difficulty removing the protective balloon cover.There was not any difficulty removing the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.There was 100% contrast used for roadmapping.The indeflator was used successfully with other devices.There was resistance/friction while inserting the balloon through the guide catheter, the guide was removed and they went bare back on the wire.The catheter was never in an acute bend.The stent was deployed in the radial artery, it was not fully inflated, and was not needed in this location but could not be removed from the patient without harm.

• Brand Name: LONG GEN / PRO 29 X 70 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8866518
• Report Number: 9616099-2019-03126
• Device Sequence Number: 2390468
• Product Code: FGE
• UDI-Device Identifier: 20705032039649
• UDI-Public: 20705032039649
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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: 02/28/2022
• Device Model Number: PG2970BPX
• Device Catalogue Number: PG2970BPX
• Device Lot Number: 82167584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67