MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400804X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a 6mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure during pre-dilation of the iliac artery.As a result, the 6mm x 4cm 135cm powerflex pro pta balloon catheter was replaced by a non-cordis balloon catheter of the same size.This was followed by the implantation of a s.M.A.R.T.Self-expanding stent (ses).After stent implantation, an 8mm x 4cm 135cm powerflex pro pta balloon catheter was to be used for post-dilation when the balloon ruptured before reaching its nominal pressure.The 8mm x 4cm 135cm pta balloon catheter was replaced by a second non-cordis balloon catheter which was used to complete the procedure.There was no reported injury to the patient.An approach was made from the left upper extremity for this procedure.Both of the devices were discarded and will not be returned.

Manufacturer Narrative

This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05745.A review of the manufacturing documentation associated with lot 82239824 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 Description

As reported, the balloon of a 6mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure during pre-dilation of the iliac artery.As a result, the 6mm x 4cm 135cm powerflex pro pta balloon catheter was replaced by a non-cordis balloon catheter of the same size.This was followed by the implantation of a s.M.A.R.T.Self-expanding stent (ses).After stent implantation, an 8mm x 4cm 135cm powerflex pro pta balloon catheter was to be used for post-dilation when the balloon ruptured before reaching its nominal pressure.The 8mm x 4cm 135cm pta balloon catheter was replaced by a second non-cordis balloon catheter which was used to complete the procedure.There was no reported injury to the patient.An approach was made from the left upper extremity for this procedure.Additional information was requested but was not provided.Both of the devices were discarded and will not be returned.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, g3, g4, g6, h1, h2, h3, h6, and h10.This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05745.Complaint conclusion: as reported, the balloon of a 6mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal pressure during pre-dilation of the iliac artery.As a result, the 6mm x 4cm 135cm powerflex pro pta balloon catheter was replaced by a non-cordis balloon catheter of the same size.This was followed by the implantation of a s.M.A.R.T.Self-expanding stent (ses).After stent implantation, an 8mm x 4cm 135cm powerflex pro pta balloon catheter was to be used for post-dilation when the balloon ruptured before reaching its nominal pressure.The 8mm x 4cm 135cm pta balloon catheter was replaced by a second non-cordis balloon catheter which was used to complete the procedure.There was no reported injury to the patient.An approach was made from the left upper extremity for this procedure.Additional information was requested but was not provided.Case-2022-00187147-2 the product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82239824 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 devices were not returned for analysis.The exact cause could not be determined.The vessel containing an implanted stent may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a lesion with a stent already implanted.The stent struts may easily damage balloon material if caution is not met when attempting to cross.It is likely this was a contributing factor to the event reported; however, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and 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.

• Brand Name: POWERFLEXPRO 8MM4CM 135
• Type of Device: 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: 14800159
• MDR Text Key: 300795646
• Report Number: 9616099-2022-05746
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059821
• UDI-Public: (01)20705032059821(17)241231(10)82239824
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4400804X
• Device Catalogue Number: 4400804X
• Device Lot Number: 82239824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2022
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (MUSTANG, BOSTON SCIENTIFIC); BALLOON CATHETER (MUSTANG, BOSTON SCIENTIFIC); UNK SMART STENT