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

Catalog Number	4400704X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 7mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured within its nominal pressure due to severe calcification.As a result, a 7mm x 4cm saberx pta balloon catheter was used as a replacement to complete the procedure.Additionally, a 6f 135cm brite tip radianz catheter sheath introducer (csi) was opened by mistake and was not clinically used.There were no reported injuries to the patient.This was during a procedure to treat a severely calcified, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa).Additional information was requested but was not provided.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of a 7mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured within its nominal pressure due to severe calcification.As a result, a 7mm x 4cm saberx pta balloon catheter was used as a replacement to complete the procedure.Additionally, a 6f 135cm brite tip radianz catheter sheath introducer (csi) was opened by mistake and was not clinically used.There were no reported injuries to the patient.This was during a procedure to treat a severely calcified, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa).The device was not returned for analysis.A product history record (phr) review of lot 82239815 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 severe calcification with a chronic occlusion likely contributed to the reported event as calcification is known to damage balloon material.The balloon material may have encountered calcified spicules during delivery or upon balloon expansion.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.Additionally, it was reported a brite tip radianz csi was opened by mistake and was not clinically used.There was no reported malfunction with this device.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.(b)(4).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.

• 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 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 17842534
• Report Number: 3007635982-2023-00308
• Device Sequence Number: 4350037
• Product Code: LIT
• UDI-Device Identifier: 20705032059708
• UDI-Public: (01)20705032059708(17)241231(10)82239815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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: 12/31/2025
• Device Catalogue Number: 4400704X
• Device Lot Number: 82239815
• Was Device Available for Evaluation?: No
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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: SABER X (7/40)
• Patient Sex: Unknown