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

Model Number N/A

Device Problem Structural Problem (2506)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82182983 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.

Event Description

As reported, the doctor felt that the marker was shorter than the balloon length (4 cm) shown in the size of the 8mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc).S/he measured it while in the patient, when it was inflated post dilation.The distance between the markers was as short as 3.5 cm.There was no reported patient injury.The device was used for post-dilation after the stent (unknown) was implanted.The device was opened in the sterile field.The device was stored and prepped as per the instructions for use (ifu).The intended procedure was a pta of the iliac artery.There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet or any of the sterile packaging components.The sterile packaging was not compromised.Other procedural details were requested but are unknown, unavailable, or not applicable.The device is expected to be returned for analysis.

Manufacturer Narrative

Complaint conclusion: as reported, the doctor felt that the marker was shorter than the balloon length (4 cm) shown in the size of the 8mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc).S/he measured it while in the patient when it was inflated post dilation.The distance between the markers was as short as 3.5 cm.There was no reported patient injury.The device was used for post-dilation after the stent (unknown) was implanted.The device was opened in the sterile field.The device was stored and prepped as per the instructions for use (ifu).The intended procedure was a pta of the iliac artery.There was no difficulty removing the product from the hoop, removing the protective balloon cover, removing the stylet or any of the sterile packaging components.The sterile packaging was not compromised.Other procedural details were requested but are unknown, unavailable, or not applicable.The product was returned for analysis.One non-sterile powerflex pro 8mm x 4cm 80 was received coiled inside a clear plastic bag.The part was unpacked to proceed with the product evaluation.The balloon was received not inflated.No damages or anomalies were observed neither on the body of the catheter nor at the balloon.A dimensional analysis was performed to verify the correct distance between the distal and the proximal marker bands.The measurement was compared against the ppe specification and the results were found within specification.A product history record (phr) review of lot 82182983 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "marker band-balloon catheters-offset/out of position - in-patient" was not confirmed during analysis of the returned device.Dimensional analysis revealed the distance between the distal and proximal marker bands were found to be within specification.According to the description in the instructions for use, ¿the cordis powerflex® pro percutaneous transluminal angioplasty (pta) catheter is a catheter with a distal inflatable balloon.Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.¿ 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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11831301
• MDR Text Key: 251087281
• Report Number: 9616099-2021-04550
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: 20705032059814
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 4400804S
• Device Lot Number: 82182983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN STENT