MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400704S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The powerflex pro 7mm x 4cm x 80 was used as a pre-dilation but it ruptured at ten atmospheres.There were no reported patient injuries.The lesion was the iliac artery which had severe calcification.The powerflex pro was replaced with a non-cordis balloon catheter and the procedure was completed.Additional procedural details were requested but are unknown.The product was not returned for analysis.A product history record (phr) review of lot 17611211 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.Vessel characteristics of severe calcification may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a severely calcified vessel.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.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.
Event or Problem Description
As reported, the powerflex pro 7mm4cm 80 was used as a pre-dilation but it ruptured at ten atmospheres.There were no reported patient injuries.The powerflex pro was replaced with a non-cordis balloon catheter and the procedure was completed.The lesion was the iliac artery which had severe calcification.The device will not be returned for analysis.Additional procedural details were requested but are unknown.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9241179
• Report Number: 9616099-2019-03308
• Device Sequence Number: 1645810
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: 20705032059692
• 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
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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: 09/30/2019
• Device Catalogue Number: 4400704S
• Device Lot Number: 17611211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1