MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400804S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, 8mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used, however, it ruptured at 4 atmospheres (atm).There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, 8mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used; however, it ruptured at four atmospheres (atm).There was no reported patient injury.The product was returned for analysis.A non-sterile powerflex pro 6mm4cm 80 was received for analysis coiled inside a plastic bag.Per visual analysis of the unit, the balloon appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation testing was performed.The balloon was inflated successfully at 15 atm (device¿s rated burst pressure) with the inflator device; neither a leakage nor a burst was observed on the balloon.A product history record (phr) review of lot 82189355 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¿ was not confirmed through analysis of the returned device.The exact cause of the reported burst could not be determined.Per functional analysis of the balloon, there was no leakage or rupture noted upon inflation during functional analysis.The device performed as intended and maintained positive pressure up to 15atm¿s, the device¿s rbp.It is likely that procedural factors and handling of the device contributed to the event reported by the customer.Therefore, based on the information available for review it is difficult to draw a clinical conclusion between the device and 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 or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 8MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11759205
• Report Number: 9616099-2021-04486
• Device Sequence Number: 11497946
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: 20705032059814
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 02/28/2023
• Device Model Number: 4400804S
• Device Catalogue Number: 4400804S
• Device Lot Number: 82189355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1