MAUDE Adverse Event Report: CORDIS DE MEXICO MAXI LD PTA F7 110 18X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4161840L

Device Problem Difficult to Remove (1528)

Patient Problem Intimal Dissection (1333)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During a valvuloplasty procedure, a 18mm x 4 cm x 110 cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter was quickly inflated and deflated, however it did not rewrap properly and was unable to be removed through the sheath.The physician pulled the sheath and the balloon out together but failed.Therefore, urgent dissection surgery was required to remove the device and repair the femoral artery.The product was removed intact in one piece from the patient.There was no other patient injury occur after the femoral artery dissection surgery repair.The patient is currently in the rehabilitation.The device will not be returned for analysis since it was discarded following the procedure.The lesion was calcified, and the device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop and protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted before inserting the product the product into the patient.The device prep normally and maintained negative pressure.The contrast to saline ratio was 50/50 and a syringe was used as the inflation device.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.Additional procedural details were requested but are unknown.

Manufacturer Narrative

During a valvuloplasty procedure, an 18mm x 4 cm x 110 cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter was quickly inflated and deflated; however, it did not rewrap properly and was unable to be removed through the sheath.The physician pulled the sheath and the balloon out together but failed.Urgent dissection surgery was required to remove the device and repair the femoral artery.The product was removed intact in one piece from the patient.There was no other reported patient injury.The valve was calcified, and the device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted before inserting the product into the patient.The device prepped normally and maintained negative pressure.The contrast to saline ratio was 50/50 and a syringe was used as the inflation device.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.Additional procedural details were requested but are unknown.The product was not returned for analysis as it was discarded following the procedure.A product history record (phr) review of lot 82162083 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon withdrawal difficulty - through guide/ sheath¿ and subsequent ¿femoral artery dissection¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Dissection is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.The physical manipulation inherent in balloon valvuloplasty procedures, intentionally disrupts the vessel plaque and intima in an effort to reconstruct viable patent vasculature and treat the atherosclerotic disease process.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.This does not represent device malfunction.Review of the available information suggests that vessel / lesion characteristics and possibly procedural factors may have contributed to this event.According to the instructions for use, which is not intended as a mitigation of risk, according to the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Carefully advance the catheter to the selected site.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 or preventive action will be taken at this time.

• Brand Name: MAXI LD PTA F7 110 18X4
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 9488712
• MDR Text Key: 175895801
• Report Number: 9616099-2019-03413
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032002230
• UDI-Public: 20705032002230
• Combination Product (y/n): N
• PMA/PMN Number: K963000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 4161840L
• Device Catalogue Number: 4161840L
• Device Lot Number: 82162083
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1