MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 7F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 504607X

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during an electrophysiology (ep) procedure, the 7 fr.Si avanti plus std w/gw no obt broke off during removal.Fluoroscopy was required to retrieve it and interventional radiology (ir)/vascular surgery was consulted for removal of the fragments.Approximately six to eight (6-8) cm.Of the distal sheath remained in the right femoral area of the patient.The sheath was ultimately removed successfully by ir.The distal tip of the sheath remained intact upon removal.The patient remained stable and was discharged.Additional information received indicated that the procedure that was being performed was an ep study- catheter ablation.There was no reported withdrawal difficulty.The sheath hub was pulled out of the groin insertion site, but the sheath shaft remained in the patient¿s body.There were no reported product issues with the sheath during the procedure that was being performed.The sheath performed well during the case despite two (2) catheter exchanges through the same sheath.The sheath broke during the pull.There was no reported insertion difficulty.The insertion site was the right femoral vein.There was no excessive force or maneuvering performed with the sheath during the procedure.The sheath shaft remained inside the patient¿s right femoral vein and required retrieval with a snare from the contralateral femoral vein.The procedure was completed successfully at the time of the reported product issue.The product was stored properly per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly per the ifu with no problems noted during preparation.No additional information is available.

Manufacturer Narrative

As reported, during an electrophysiology (ep) procedure, the 7 fr.Si avanti plus std w/gw no obt broke off during removal.Fluoroscopy was required to retrieve it and interventional radiology (ir)/vascular surgery was consulted for removal of the fragments.Approximately six to eight (6-8) cm.Of the distal sheath remained in the right femoral area of the patient.The sheath was ultimately removed successfully by ir.The distal tip of the sheath remained intact upon removal.The patient remained stable and was discharged.Additional information received indicated that the procedure that was being performed was an ep study-catheter ablation.There was no reported withdrawal difficulty.The sheath hub was pulled out of the groin insertion site, but the sheath shaft remained in the patient¿s body.There were no reported product issues with the sheath during the procedure that was being performed.The sheath performed well during the case despite two (2) catheter exchanges through the same sheath.The sheath broke during the pull.There was no reported insertion difficulty.The insertion site was the right femoral vein.There was no excessive force or maneuvering performed with the sheath during the procedure.The sheath shaft remained inside the patient¿s right femoral vein and required retrieval with a snare from the contralateral femoral vein.The procedure was completed successfully at the time of the reported product issue.The product was stored properly per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly per the ifu with no problems noted during preparation.No additional information is available.One non-sterile si avanti+ 7f std w/gw no obt cannula was received inside a plastic bag for analysis.A separation was observed at 10cm from the distal end.No other discrepancies were found on the unit received.During microscopic analysis, elongations were observed in the separated section.A review of the manufacturing documentation associated with lot 17765496 was performed and it was found that the phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.The event "cannula - separated - in patient" reported by the customer was confirmed due to the condition in which the unit was received.The exact cause of the event could not be conclusively determined.Procedural/handling factors, such as stretching or pulling, appear to have impacted the event experienced by the customer due to the elongations noted during the analysis.According to the product instructions for use, users are cautioned that if increased resistance is felt upon insertion or withdrawal of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.Neither the product analysis nor the product history record review suggests that the event could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: SI AVANTI+ 7F STD W/GW NO OBT
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7748011
• MDR Text Key: 115960767
• Report Number: 9616099-2018-02286
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 504607X
• Device Lot Number: 17765496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention