MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 12MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401204S
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the balloon of a 12mm x 4cm 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured horizontally during an inflation to treat a left brachial cephalic vein (bcv) occlusion.The balloon had burst during an inflation to 8 atmospheres (atm), and the rupture caused part of the balloon to detach from the powerflex pro balloon catheter.As a result, the 12mm x 4cm powerflex pro balloon catheter and an unknown catheter sheath introducer (csi) were removed from the patient over a storq guidewire that was being used for the procedure.After removal of the balloon and unknown csi, a neck incision was made at the skin level of the access site and the separated portion of the balloon was removed with a pair of surgical forceps.Prior to the balloon rupture, the lesion was pre-dilated with a 3mm.018 saber pta balloon catheter.This was followed by further pre-dilation with a 6mm powerflex pro pta balloon catheter, and then a 10mm powerflex pro pta balloon catheter.The 12mm x 4cm 80cm powerflex pro was stored and prepped per the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to easily track towards the lesion and was never put into an acute bend.Information regarding the patient, and information regarding other cordis products used during this procedure was requested but was not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82236786 presented no issues during the manufacturing process that can be related to the reported event.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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, and h10.The device was previously reported as received on 01-aug-2022; however, only a picture of the device was received on 01-aug-2022.The device has not been received; however, the return of the device is still expected.Additional information is pending and will be submitted within 30 days upon receipt.
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.
Additional Manufacturer Narrative
Complaint conclusion: the balloon of a 12mm x 4cm 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured horizontally during an inflation to treat a left brachial cephalic vein (bcv) occlusion.The balloon had burst during an inflation to 8 atm (eight atmospheres), and the rupture caused part of the balloon to detach from the powerflex pro balloon catheter.As a result, the 12mm x 4cm powerflex pro balloon catheter and an unknown catheter sheath introducer (csi) were removed from the patient over a storq guidewire that was being used for the procedure.After removal of the balloon and unknown csi, a neck incision was made at the skin level of the access site and the separated portion of the balloon was removed with a pair of surgical forceps.Prior to the balloon rupture, the lesion was pre-dilated with a 3mm.018 saber pta balloon catheter.This was followed by further pre-dilation with a 6mm powerflex pro pta balloon catheter, and then a 10mm powerflex pro pta balloon catheter.The 12mm x 4cm 80cm powerflex pro was stored and prepped per the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to easily track towards the lesion and was never put into an acute bend.Information regarding the patient, and information regarding other cordis products used during this procedure was requested but was not provided.The product was returned for analysis.Previously, a picture analysis was performed on this complaint since, at that time, no product was received for analysis, instead one picture related to the reported failure was attached by the customer at the complaint file (b)(4).Per picture verification, it showed a coiled catheter, and a balloon burst was noted.Also, blood residues were observed.No other anomalies of the product were noted in the picture provided.At time of picture review, the event reported as balloon separated could not be confirmed as part of the picture analysis.A non-sterile powerflex pro 12mm x 4cm 80cm percutaneous transluminal angioplasty (pta) balloon catheter, along with a cordis 7f csi, were received for analysis inside a plastic bag.The powerflex was received inserted in the csi.Per visual analysis of the units, no anomalies were observed on the csi.However, the balloon was found ruptured /separated at the middle balloon area.No other physical characteristics could be seen.Per sem analysis the balloon of the powerflex pro 12mm x 4cm 80cm device presented evidence of a rupture condition and scratch marks near the separation/rupture area.This type of damage is 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 damaged condition found.It seems the material adjacent to the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.The reported ¿balloon- separated - in-patient¿ and ¿balloon burst-at/below rbp¿ was confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, procedural and/or handling factors may have contributed to the burst as evidenced by a rupture condition and scratch marks near the separation area noted during analysis.According to 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 (b)(4) of the balloons (with a (b)(4) 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 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.

• Brand Name: POWERFLEXPRO 12MM4CM 80
• 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: 15264920
• Report Number: 9616099-2022-05908
• Device Sequence Number: 5731931
• Product Code: LIT
• UDI-Device Identifier: 20705032060179
• UDI-Public: (01)20705032060179(17)241130(10)82236786
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 4401204S
• Device Catalogue Number: 4401204S
• Device Lot Number: 82236786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 09/20/2022; 10/23/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/16/2022; 10/14/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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: 10MM POWERFLEX PRO BALLOON; 3MM (018 SABER BALLOON); 6MM POWERFLEX PRO BALLOON; STORQ WIRE; UNK FORCEPS; UNK SHEATH; UNK WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown