MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400802S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An 8mm x 2cm powerflex pro percutaneous coronary angioplasty (pta) balloon catheter (bc) was inflated as a pre-dilation; however, it ruptured within its nominal pressure.No patient injury was reported.The lesion was the iliac artery.The powerflex pro was replaced with a new unknown device and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 17648036 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.With the paucity of information available and without return of the product for analysis, it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to 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/preventive action will be taken at this time.
Event or Problem Description
As reported, an 8mmx2cm powerflex pro percutaneous coronary angioplasty (pta) balloon catheter (bc) was inflated as a pre-dilation, however it ruptured within its nominal pressure.No patient injury was reported.The lesion was the iliac artery.The powerflex pro was replaced with a new unknown device and the procedure was completed.The device was discarded in the hospital.
Event or Problem Description
As reported, an 8mmx2cm powerflex pro percutaneous coronary angioplasty (pta) balloon catheter (bc) was inflated as a pre-dilation, however it ruptured within its nominal pressure.No patient injury was reported.The lesion was the iliac artery.The device was inspected and prepped per the instructions for use (ifu), and it prepped normally (i.E.Maintain negative pressure).The bc was removed easily and intact (in one piece) from the patient.The powerflex pro was replaced with a new unknown device and the procedure was completed.The device was discarded in the hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g4, g7, and h2 have been updated accordingly.Section b5 description of event: as reported, an 8mmx2cm powerflex pro percutaneous coronary angioplasty (pta) balloon catheter (bc) was inflated as a pre-dilation, however it ruptured within its nominal pressure.No patient injury was reported.The lesion was the iliac artery.The device was inspected and prepped per the instructions for use (ifu), and it prepped normally (i.E.Maintain negative pressure).The bc was removed easily and intact (in one piece) from the patient.The powerflex pro was replaced with a new unknown device and the procedure was completed.The device was discarded in the hospital.An 8mm x 2cm powerflex pro percutaneous coronary angioplasty (pta) balloon catheter (bc) was inflated as a pre-dilation; however, it ruptured within its nominal pressure.No patient injury was reported.The lesion was the iliac artery.The device was inspected and prepped per the instructions for use (ifu), and it prepped normally (i.E.Maintain negative pressure).The bc was removed easily and intact (in one piece) from the patient.The powerflex pro was replaced with a new unknown device and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 17648036 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.With the paucity of information available and without return of the product for analysis, it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to 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/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 8MM2CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8782153
• Report Number: 9616099-2019-03070
• Device Sequence Number: 11247151
• Product Code: LIT
• UDI-Device Identifier: 20705032059777
• UDI-Public: 20705032059777
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 01/31/2020
• Device Catalogue Number: 4400802S
• Device Lot Number: 17648036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1