MAUDE Adverse Event Report: CORDIS CORPORATION SDS GENESIS .035 10.0X29 80; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number PG2910PPS

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, prior to releasing the stent of a 10mm x 29mm 80cm palmaz genesis on.035 opta pro stent-delivery system (sds), the stent was already visible.There was no reported injury to the patient and the event did not require hospitalization or significant prolongation of an existing hospital stay.This was during an interventional procedure.The lesion was not a chronic total occlusion (cto).The device was prepped per the instructions for use (ifu) without difficulty, and the stent was not manipulated during preparation.The device will be retuned for evaluation.

Manufacturer Narrative

Complaint conclusion: prior to releasing the stent of a 10mm x 29mm 80cm palmaz genesis on.035 opta pro stent-delivery system (sds), the stent was already visible.There was no reported injury to the patient and the event did not require hospitalization or significant prolongation of an existing hospital stay.This was during an interventional procedure.The lesion was not a chronic total occlusion (cto).The device was prepped per the instructions for use (ifu) without difficulty, and the stent was not manipulated during preparation.The product was not returned for analysis.A product history record (phr) review of lot 82211298 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent premature deployment¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is not known what may have contributed to this reported event due to the paucity of information provided.The event description itself does not reflect how this device is either deployed or used, as the stent sits atop a folded balloon and is always visible.According to the precautions in the safety information in the instructions for use ¿the device should only be used by physicians who are trained in interventional techniques such as pta, placement of stents and transhepatic access.Prior to stenting, the palmaz genesis peripheral stent on opta pro.035" delivery system should be examined to verify functionality and integrity.To assure full expansion, inflate to at least the recommended nominal pressure as shown on the label.When catheters are in the body, they should be manipulated only under fluoroscopy.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.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.Under fluoroscopy, use the balloon marker bands and the radiopaque stent to position the stent centrally within the lesion.During positioning, verify that the stent is still centered within the balloon marker bands and has not been dislodged.Prior to stent expansion, ensure that stent and balloon are completely exposed from the csi or guiding catheter.¿ 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.

Event Description

As reported, prior to releasing the stent of a 10mm x 29mm 80cm palmaz genesis on.035 opta pro stent-delivery system (sds), the stent was already visible.There was no reported injury to the patient and the event did not require hospitalization or significant prolongation of an existing hospital stay.This was during an interventional procedure.The lesion was not a chronic total occlusion (cto).The device was prepped per the instructions for use (ifu) without difficulty, and the stent was not manipulated during preparation.The device was discarded and will not be returned.

• Brand Name: SDS GENESIS .035 10.0X29 80
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15403027
• MDR Text Key: 299703127
• Report Number: 9616099-2022-05960
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032039458
• UDI-Public: (01)20705032039458(17)231231(10)82211298
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K012590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: PG2910PPS
• Device Lot Number: 82211298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/04/2022
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other