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

Model Number	4400322X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 3mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) during its initial inflation.As a result, a 3mm x 15mm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.The balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion.There was no tortuosity at the lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.The device was able to be removed easily and remained in one piece during its removal.The device will be returned for evaluation.
Event or Problem Description
As reported, the balloon of a 3mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) during its initial inflation.As a result, a 3mm x 15mm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.The balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion.There was no tortuosity at the lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.The device was able to be removed easily and remained in one piece during its removal.The device was not returned as expected.
Additional Manufacturer Narrative
Correction made to section b5: the event description was updated to reflect that the device was not returned as expected.Complaint conclusion: as reported, the balloon of a 3mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) during its initial inflation.As a result, a 3mm x 15mm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.The balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion.There was no tortuosity at the lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.The device was able to be removed easily and remained in one piece during its removal.The device was not returned for analysis.A product history record (phr) review of lot 82237915 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of a chronically occluded lesion likely contributed to the reported event as it was stated ¿the balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion¿.However, without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.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.¿ 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d4, d9, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the balloon of a 3mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) during its initial inflation.As a result, a 3mm x 15mm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.The balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion.There was no tortuosity at the lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.The device was able to be removed easily and remained in one piece during its removal.The device was not returned for analysis.A product history record (phr) review of lot 82237915 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of a chronically occluded lesion likely contributed to the reported event as it was stated ¿the balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion¿.However, without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.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.¿ 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.
Event or Problem Description
As reported, the balloon of a 3mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 10 atmospheres (atm) during its initial inflation.As a result, a 3mm x 15mm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.The balloon ruptured while attempting to dilate a chronic totally occluded (cto) atherosclerotic anterior tibial lesion.There was no tortuosity at the lesion.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.The device was able to be removed easily and remained in one piece during its removal.The device will be returned for evaluation.

• 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 FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17183362
• Report Number: 3007635982-2023-00219
• Device Sequence Number: 6391580
• Product Code: LIT
• UDI-Device Identifier: 20705032059111
• UDI-Public: (01)20705032059111(17)241031(10)82237915
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

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: 10/31/2024
• Device Model Number: 4400322X
• Device Catalogue Number: 4400322X
• Device Lot Number: 82237915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 07/20/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/20/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: 3MM X 15MM ABBOT BALLOON
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 98 KG