MAUDE Adverse Event Report: CORDIS US. CORP POWERFLEX PRO; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400602S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82208685 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 or Problem Description
As reported, the balloon of a 6mm x 20mm 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured prior to reaching its nominal pressure during a pre-dilation inflation.As a result, an unknown balloon catheter was used to continue the procedure and a non-cordis stent was implanted.The unknown balloon catheter was used for post-dilation and the procedure was completed.There were no reported injuries to the patient.This was during an interventional procedure to treat a lesion in the iliac artery.An ipsilateral retrograde approach was used for this procedure.Additional information was requested but was unavailable.The device was not returned as expected.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 6mm x 20mm 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured prior to reaching its nominal pressure during a pre-dilation inflation.As a result, an unknown balloon catheter was used to continue the procedure and a non-cordis stent was implanted.The unknown balloon catheter was used for post-dilation and the procedure was completed.There were no reported injuries to the patient.This was during an interventional procedure to treat a lesion in the iliac artery.An ipsilateral retrograde approach was used for this procedure.Additional information was requested but was unavailable.The device has now been returned.
Additional Manufacturer Narrative
Complaint conclusion: the balloon of a 6mm x 20mm 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured prior to reaching its nominal pressure during a pre-dilation inflation.As a result, an unknown balloon catheter was used to continue the procedure and a non-cordis stent was implanted.The unknown balloon catheter was used for post-dilation and the procedure was completed.There were no reported injuries to the patient.This was during an interventional procedure to treat a lesion in the iliac artery.An ipsilateral retrograde approach was used for this procedure.Additional information was requested but was unavailable.The product was returned for analysis.A non-sterile powerflex pro 6mm x 2cm 80cm bc was received coiled inside of a clear plastic bag.Per visual analysis no damages or anomalies were observed during the unaided eye visual inspection.The balloon was received uninflated.Per functional analysis a balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reach the rated burst pressure.A leak was noted to be present in the balloon that did not permit the maintenance of pressure during the inflation, as expected.A guide wire from the cordis lab was introduced and neither obstruction nor friction was detected that could impede the insertion of the guidewire.Per sem analysis a burst condition was observed as a puncture that presented scratch marks adjacent to the affected burst area.These types of damages are commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon likely led to the burst condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed.A product history record (phr) review of lot 82208685 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 confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) may have contributed to the event as evidenced by scratch marks noted on the outer surface during analysis.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.¿ 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.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17669580
• Report Number: 3007635982-2023-00285
• Device Sequence Number: 17918454
• Product Code: LIT
• UDI-Device Identifier: 20705032059463
• UDI-Public: (01)20705032059463(17)231130(10)82208685
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 4400602S
• Device Lot Number: 82208685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 10/31/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/06/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO RADIO FOCUS 260CM
• Patient Sex: Unknown