MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM8CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4400708S

Device Problems Material Frayed (1262); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.  however, it will be submitted within 30 days upon receipt.(b)(4).

Event Description

As reported, during a left arm fistula the physician inflated and deflated a power flex pro 7 mm 8 cm 80 multiple times, fully deflated and removed.Upon removal of the power flex pro 7 mm 8 cm 80 balloon it got stuck on the stent and shredded the balloon inside the patient.  the device was prepared as specified by the instructions for use.  there was no apparent damage to the device noticed prior to use.  the device did not pass through any acute bends as it was a fistula.  there was no  difficulty encountered while advancing/tracking the device towards the lesion.  the access site was the left fistula.  a contralateral approach was not used.  the vessel characteristics at target site had stenosis, but no calcification.  there was no patient injury due to the device malfunction. the product was not removed intact (in one piece) from the patient.The separated segment was removed surgically the following day.The patient was discharged and doing fine.

Manufacturer Narrative

As reported, the physician inflated and deflated a powerflex pro 7x80mm 80cm multiple times, and fully deflated the balloon.However, upon removal of the powerflex pro balloon, it got stuck on the stent and shredded the balloon inside the patient.The product was not removed intact, and the separated segment was removed surgically the following day. there was no patient injury due to the device malfunction.The patient was discharged and doing fine.The device was prepared as specified by the instructions for use.There was no apparent damage to the device noticed prior to use.The device did not pass through any acute bends as it was a fistula.There was no difficulty encountered while advancing/tracking the device towards the lesion.The access site was the left fistula.A contralateral approach was not used.The vessel characteristics at target site had stenosis, but no calcification.The non-sterile distal part of a powerflex pro 7mm8cm 80 was received inside a plastic bag separated in two sections.Per visual analysis, it was noticed that the balloon presented a rupture/ separation at its middle section.Additionally, the inner body was separated at the balloon¿s distal section.No other issues were found.The unit was sent to sem analysis and results showed that the external surface of balloon presented evidence of scratches near to the balloon rupture.It¿s very likely that the same factors that caused the scratches on the balloon¿s outer surface could have also contributed to the rupture found on the received balloon.The internal surface did not present any evidence of damages.The catheter body separated sections presented evidence of elongations.Also, scratches and ruptured areas were observed on the outer wall of the inner body, close to the body separation.Those characteristics suggest that the device was induced to stretching/pulling events that exceeded the material¿s yield strength prior to the separation.No other issues were noted during sem analysis.No other anomalies were found during the analysis.A device history record (dhr) review could not be conducted as a lot number was not provided.The reported ¿balloon- withdrawal difficulty - snagged/caught on stent¿ could not be confirmed since functional analysis could not be performed due to the condition of the returned device and due to the nature of the complaint.However, the reported ¿balloon separated ¿ in patient¿ and ¿frayed/ split/torn ¿ in patient¿ were confirmed through analysis of the returned device.The cause of the balloon rupture/separation and inner body separation found could not be conclusively determined during the analysis.Based on the limited information available for review, procedural/handling factors (caught on the deployed stent) may have contributed to the withdrawal difficulty, balloon tear and subsequent separations as evidenced by the scratches on the balloon¿s outer surface, and the presence of elongations, scratches and ruptures at the separated section noted during sem analysis.According to the instructions for use (ifu), which is not intended as a mitigation, ¿if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the product analysis nor the information available suggests that the event experienced by the customer could be related to the design or manufacturing process.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 7MM8CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6665398
• MDR Text Key: 78458524
• Report Number: 9616099-2017-01195
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4400708S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention