MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400615X
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the physician was not able to reinsert the powerflex pro 6mm 15cm balloon through a 6f 55cm non-cordis sheath because the balloon would not rewrap.Physician had previously used the balloon for one inflation and struggled to remove the balloon through the sheath.The device was removed intact from the patient.The case was completed with a new unknown balloon.There was no reported injury to the patient.The device was stored at proper room temperature on a cart.The device was stored per the instructions for use (ifu).There was no difficulty removing the product from the hoop, protective balloon cover, removing the stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was prepped normally.The device was able to maintain negative pressure.The intended lesion was in the superficial femoral artery (sfa).The lesion was noted to have moderate calcification.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no difficulty advancing the balloon through the vessel and the balloon crossed the lesion without difficulty.The device was never in an acute bend.The balloon was re-prepped before attempting to insert for the second time.Deflation of the balloon was longer than desired as it took 15-20 seconds to deflate.The balloon was deflated by puling negative pressure multiple times.The balloon was not deflated completely but it was enough to remove from the patient.The non-cordis inflation device was filled with a 70:30 saline/contrast ratio.The same inflation device was used successfully with other devices during the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the physician was not able to reinsert the powerflex pro 6mm 15cm balloon through a 6f 55cm non-cordis sheath because the balloon would not rewrap.Physician had previously used the balloon for one inflation and struggled to remove the balloon through the sheath.The device was removed intact from the patient.The case was completed with a new unknown balloon.There was no reported injury to the patient.The device was stored at proper room temperature on a cart.The device was stored per the instructions for use (ifu).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 prior to inserting the product into the patient.The device was prepped per the ifu and was prepped normally.The device was able to maintain negative pressure.The intended lesion was in the superficial femoral artery (sfa).The lesion was noted to have moderate calcification.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no difficulty advancing the balloon through the vessel and the balloon crossed the lesion without difficulty.The device was never in an acute bend.The balloon was re-prepped before attempting to insert for the second time.Deflation of the balloon was longer than desired as it took 15-20 seconds to deflate.The balloon was deflated by puling negative pressure multiple times.The balloon was not deflated completely but it was enough to remove from the patient.The non-cordis inflation device was filled with a 70:30 saline/contrast ratio.The same inflation device was used successfully with other devices during the procedure.The device was returned for analysis.A non-sterile powerflex pro 6mm x 15cm 135 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag.The mentioned concomitant non-cordis catheter sheath used in the procedure was not returned with the unit.Per visual analysis, the powerflex pro was received partially deflated, and a section of the balloon material was observed bulged up on itself.No other damages on the unit could be observed.Insertion/withdrawal test was performed on the unit.The balloon was deflated, and an appropriate.035¿ emerald guidewire lab sample was pass through the unit via hub.Then, the powerflex pro was inserted/withdrawn through a compatible 5f cordis catheter sheath lab sample with successful results.A product history record (phr) review of lot 82239813 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon re-wrapping difficulty¿ and ¿balloon withdrawal difficulty- through guide/sheath¿ were not confirmed during analysis of the returned device as received.The exact cause cannot be determined.The balloon was returned in poor condition and the balloon material appeared to be bulged up on itself during visual inspection.Additionally, the loss of the original pleat on the balloon was noted on the images of the returned device.Inflations of the balloon during treatment can affect the return of the balloon pleats to their original profile.Nevertheless, functional analysis was performed successfully with a 5f lab sample with no difficulties noted during insertion/withdrawal testing or upon deflation of the balloon.It was noted that a 6f non-cordis csi was used intra-procedurally; therefore, it is assumed by these findings along with the interactions between the concomitant devices, may have contributed to the failures reported as evidenced by device analysis.Handling and procedural factors that are not limited to, patient¿s anatomy, lesion¿s severity in calcification, and/or stenosis were likely additional factors to the events as the bulging of the balloon material is suggestive of forceful handling during removal.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.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.If resistance is met during manipulation, determine the cause of the resistance before proceeding.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.
Event or Problem Description
As reported, the physician was not able to reinsert the powerflex pro 6mm 15cm balloon through a 6f 55cm non-cordis sheath because the balloon would not rewrap.Physician had previously used the balloon for one inflation and struggled to remove the balloon through the sheath.The device was removed intact from the patient.The case was completed with a new unknown balloon.There was no reported injury to the patient.The device was stored at proper room temperature on a cart.The device was stored per the instructions for use (ifu).There was no difficulty removing the product from the hoop, protective balloon cover, removing the stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was prepped normally.The device was able to maintain negative pressure.The intended lesion was in the superficial femoral artery (sfa).The lesion was noted to have moderate calcification.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no difficulty advancing the balloon through the vessel and the balloon crossed the lesion without difficulty.The device was never in an acute bend.The balloon was re-prepped before attempting to insert for the second time.Deflation of the balloon was longer than desired as it took 15-20 seconds to deflate.The balloon was deflated by puling negative pressure multiple times.The balloon was not deflated completely but it was enough to remove from the patient.The non-cordis inflation device was filled with a 70:30 saline/contrast ratio.The same inflation device was used successfully with other devices during the procedure.The device will be returned for evaluation.

• Brand Name: POWERFLEXPRO 6MM15CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15951895
• Report Number: 9616099-2022-06147
• Device Sequence Number: 7334913
• Product Code: LIT
• UDI-Device Identifier: 20705032059623
• UDI-Public: (01)20705032059623(17)241231(10)82239813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 4400615X
• Device Catalogue Number: 4400615X
• Device Lot Number: 82239813
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: 6F 55CM COOK SHEATH; UNK BALLOON CATH
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 85 KG