MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400615X

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number has been corrected and updated, therefore the product history review (phr) is pending.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when the physician attempted to remove the 135 powerflexpro 6 mm.X 15 cm.Pta catheter balloon from the patient, the balloon went into the sheath, but would not fully enter.The balloon accordioned and the catheter stretched with each subsequent removal attempt.In the end, the only option was to remove both the sheath and the balloon together, at which point the doctor cut the balloon to remove it.A new sheath was inserted and the procedure was completed successfully.The powerflex pro dilatation catheter failed to properly rewrap after multiple inflations.There was a 5 fr.Non-cordis sheath up and over the aorto-iliac bifurcation and the 260 cm.Non-cordis wire was angled regular.The balloon was inserted into the sheath and while some resistance was anticipated, the balloon tracked well through the length of the sheath to the target lesion.The entire superficial femoral artery was ballooned (multiple inflations). the products were not saved, and will not be able to be returned.Additional information has been received.The sheath and balloon were completely removed from the patient before being reportedly cut.As reported by the representative, the doctor wanted to use the sheath again, but the balloon was stuck inside.It is unknown where exactly the balloon was cut, but somewhere along the balloon since it had ¿accordioned¿ partially inside the sheath.After cutting, the physician still had difficulty removing it, and since hemostasis was of priority, he opted to use a new sheath and trashed the balloon and the original ansel sheath.The vessel was reported as a 5-7 mm superficial femoral artery (sfa) with no noticeable tortuosity or severe calcification.There were no product issues noted with the sheath.There was no reported patient injury.There was no other product issue noted either at the account or after the procedure.There was no difficulty removing the product from the hoop.There was no separation of the distal tip reported.The shipping stylet and balloon cover were attempted to be removed before submerging in heparinized saline solution.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no tortuosity encountered during advancement of the device/during manipulation, and there was only minor difficulty encountered during advancement of the device.

Manufacturer Narrative

Complaint conclusion-as reported, when the physician attempted to remove the 135 powerflex pro 6 mm.X 15 cm.Pta catheter balloon from the patient, the balloon went into the sheath, but would not fully enter.The balloon accordioned and the catheter stretched with each subsequent removal attempt.In the end, the only option was to remove both the sheath and the balloon together, at which point the doctor cut the balloon to remove it.A new sheath was inserted and the procedure was completed successfully.The powerflex pro dilatation catheter failed to properly rewrap after multiple inflations.There was a 5 fr.Non-cordis sheath up and over the aorto-iliac bifurcation and the 260 cm.Non-cordis wire was angled regular.The balloon was inserted into the sheath and while some resistance was anticipated, the balloon tracked well through the length of the sheath to the target lesion.The entire superficial femoral artery was ballooned (multiple inflations).The sheath and balloon were completely removed from the patient before being reportedly cut.As reported by the representative, the doctor wanted to use the sheath again, but the balloon was stuck inside.It is unknown where exactly the balloon was cut, but somewhere along the balloon since it had ¿accordioned¿ partially inside the sheath.After cutting, the physician still had difficulty removing it, and since hemostasis was of priority, he opted to use a new sheath and trashed the balloon and the original ansel sheath.The vessel was reported as a 5-7 mm superficial femoral artery (sfa) with no noticeable tortuosity or severe calcification.There were no product issues noted with the sheath.There was no reported patient injury.There was no other product issue noted either at the account or after the procedure.There was no difficulty removing the product from the hoop.There was no separation of the distal tip reported.The shipping stylet and balloon cover were attempted to be removed before submerging in heparinized saline solution.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no tortuosity encountered during advancement of the device/during manipulation, and there was only minor difficulty encountered during advancement of the device.The device was not returned for analysis.A device history record (dhr) review of lot 17206195 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon withdrawal difficulty - through guide/ sheath¿ and ¿balloon re-wrapping difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.However, procedural factors (failed to rewrap properly) may have contributed to the withdrawal difficulty reported according to the instructions for use ¿do not advance or retract the catheter unless the balloon is fully deflated under vacuum.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 dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: POWERFLEXPRO 6MM15CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32580 ; MX 32580
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6203748
• MDR Text Key: 63263327
• Report Number: 9616099-2016-00817
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 4400615X
• Device Catalogue Number: 4400615X
• Device Lot Number: 17206195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/05/2017
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 5 FRENCH 55 CM COOK MEDICAL ANSEL SHEATH260 CM A