MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82177560 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During the operation, the balloon of a 10mm x 2cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter exploded when the doctor tried to inflate it and all of the ¿front piece¿ of the balloon catheter remained inside the patient.Therefore, the doctor who was operating the patient asked for a surgeon to remove the piece that was still inside the patient and after the intervention, the patient was okay.The product was stored as per labeling.The device was opened in a sterile field.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: during the operation, the balloon of a 10mm x 2cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter exploded when the doctor tried to inflate it and all of the ¿front piece¿ of the balloon catheter remained inside the patient.Therefore, the doctor who was operating on the patient asked for a surgeon to remove the piece that was still inside the patient and after the intervention, the patient was okay.The lesion had moderate to severe calcification, moderate tortuosity, mild angulation of about 20 degree, about 60% stenosis, and was not a chronic total occlusion (cto).The product was stored as per labeling.The device was opened in a sterile field.Surgical intervention was not necessary to remove the separated piece.The event caused an 120 minute increase in duration of the procedure.The event did not cause hospitalization or prolonged hospitalization.The procedure was to prepare for a transcatheter pulmonary valve replacement.There were no anomalies noted when removed from the package or during prep.The device was stored and prepped according to the instructions for use (ifu).The device was inserted through a hemostatic valve.The balloon was not caught in the lesion or in a deployed stent.There was no resistance met while advancing or withdrawing the device.No excessive torque was required.There was no resistance met while advancing the device over the guidewire.The device did not kink in the area of separation.The device separated at the end of the balloon.The patient is doing well.Other procedural details were requested but are unknown, unavailable, or not applicable.The product was returned for analysis.A non-sterile unit of a powerflex pro 10mm x 2cm 80cm balloon catheter (bc) was received for analysis coiled inside a plastic bag.Also, a 6f non-cordis catheter sheath introducer (csi) was received inside the plastic bag.Per visual analysis, the body/shaft of the bc was observed separated at its distal end.The balloon was observed separated from the unit, nevertheless, it seems it got stuck inside the received non cordis csi cannula.Also, the non-cordis csi cannula was observed accordioned as received.No other anomalies were observed.Per functional analysis a balloon inflation to verify if it¿s burst couldn¿t be performed on the balloon since the balloon was received separated from the unit.Per sem analysis on the separated area of the body/shaft showed that the body/shaft of the powerflex pro bc presented evidence of elongations and cup and cone shape-like on the body/shaft material.No other anomalies were observed.The elongations and the cup and cone shape-like found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 82191291 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ was not confirmed through analysis of the returned device due to the condition of the returned device.The reported ¿distal tip - separated - in-patient¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Nevertheless, sem analysis results showed that the separated area observed on the body/shaft material presented evidence of elongations and cup and cone shape-like damages.These damages found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the material separation.Also, the non-cordis csi cannula was observed accordioned.Per the observed damages observed on the body/shaft of the unit and the csi cannula, it could be suggested that procedural factors and/ or handling process may have contributed to the observed damages of the unit.According to the instructions for use, which is not intended as a mitigation of risk, ¿do not advance or retract the catheter unless the balloon is fully deflated under vacuum.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the phr review nor the product analysis suggests 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.

Event Description

During the operation, the balloon of a 10mm x 2cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter exploded when the doctor tried to inflate it and all of the ¿front piece¿ of the balloon catheter remained inside the patient.Therefore, the doctor who was operating the patient asked for a surgeon to remove the piece that was still inside the patient and after the intervention, the patient was okay.The product was stored as per labeling.The device was opened in a sterile field.Surgical intervention was not necessary to remove the separated piece.The event caused an 120 minute increase in duration of the procedure.The event did not cause hospitalization or prolonged hospitalization.The procedure was to prepare for a transcatheter pulmonary valve replacement.The lesion had moderate to severe calcification, moderate tortuosity, mild angulation of about 20 degree, about 60% stenosis, and was not a chronic total occlusion (cto).There were no anomalies noted when removed from the package or during prep.The device was stored and prepped according to the instructions for use (ifu).The device was inserted through a hemostatic valve.The balloon was not caught in the lesion or in a deployed stent.There was no resistance met while advancing or withdrawing the device.No excessive torque was required.There was no resistance met while advancing the device over the guidewire.The device did not kink in the area of separation.The device separated at the end of the balloon.The patient is doing well.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.

• Brand Name: POWERFLEXPRO 10MM2CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10494488
• MDR Text Key: 205713557
• Report Number: 9616099-2020-03885
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032060018
• UDI-Public: 20705032060018
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 4401002S
• Device Lot Number: 82177560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 46