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

Catalog Number	4400615X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17719796) presented no issues during the manufacturing process that can be related to the reported event.This is one of two products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-02864.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During the peripheral angioplasty, the powerflex pro pta (6mm x 15cm 135cm) balloon catheter (bc) did not pass over the guidewire, there was much resistance; therefore, another balloon was used and worked well.There was no reported patient injury.The device was stored and handled per the instructions for use ifu.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.There were no kinks noted on the device prior to use.The device was prepped according to instructions for use (ifu).The catheter was flushed with heparinized saline.The insertion difficulty was reportedly caused by a blockage of possibly injectable material.There was no excessive force applied on the device while attempting to insert it over the guide wire.Other products were successfully used with the device prior to the encountered resistance.The catheter was not torqued against resistance.There was no unusual force used at any time during the procedure.The difficulty require that only the reported product was removed.The device was removed intact (in one piece) from the patient.The procedure was completed with another balloon.The procedure was completed successfully without patient injury.There are no procedural films available.The device will be returned for analysis.A 6f vista brite tip catheter sheath introducer was used in the procedure.Additional information received indicates that the injection was only a saline solution.There was no thrombus reported.
Additional Manufacturer Narrative
After further review of additional information received the following sections and have been updated accordingly.During a peripheral angioplasty, the powerflex pro pta (6mm x 15cm x 135cm) balloon catheter (bc) did not pass over the guidewire.There was much resistance, therefore another balloon was used and worked well.There was no reported patient injury.The insertion difficulty was reportedly caused by a blockage of possibly injectable material.There was no excessive force applied on the device while attempting to insert it over the guide wire.The catheter was not torqued against resistance and no unusual force was used at any time during the procedure.Other products were successfully used with the device prior to the encountered resistance.The device was removed intact (in one piece) from the patient and the procedure was completed successfully with another balloon.The device was stored, handled, and prepped per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty removing the product from the packaging.There were no kinks noted on the device prior to use.The catheter was flushed with heparinized saline.A 6f vista brite tip catheter sheath introducer was used in the procedure.Additional information received indicates that the injection was only a saline solution.There was no thrombus reported.One product was returned for analysis.A non-sterile powerflex pro balloon catheter (6mm x 15cm x 135cm) was returned.Per visual analysis, the catheter was coiled inside a plastic bag and no other anomalies were noted.Dimensional analysis for od proximal seal was performed and was found within specification.The balloon catheter was passed through a cordis lab sample sheath.Resistance was experienced during the insertion test at approximately 3cm from the distal tip up to 2cm from the proximal seal, in the balloon area.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied; the balloon inflated as expected.During sem analysis, an elongated area was identified near the distal seal.This area presented evidence of scratches, as well as stretch marks and outer diameter reduction.The outer diameter reduction and stretch marks suggest that the device was induced to stretching/pulling events that led to the elongation.No other issues were observed during the sem analysis.A product history record (phr) review of lot 17719796 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- obstructed¿ was confirmed through analysis of the returned device, resistance and a narrowed od was noted in the balloon area during the functional test and sem analysis.The exact cause of the obstruction could not be determined.However, sem analysis suggests the resistance may have been related to the elongation adjacent to the distal seal due to stretching/pulling events.There was no evidence of ¿injectable material¿ as initially suspected by the customer.The analyzed device indicates the potential for ¿necking¿ of the catheter which could impair the ability to introduce a guidewire through the lumen due to the narrowing of the guidewire lumen, which usually occurs during ¿necking¿.Therefore, procedural and handling factors may have contributed to this reported event.According to the safety information in the instructions for use ¿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.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM15CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8559540
• Report Number: 9616099-2019-02880
• Device Sequence Number: 19566917
• Product Code: LIT
• UDI-Device Identifier: 20705032059623
• UDI-Public: 20705032059623
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 08/31/2020
• Device Catalogue Number: 4400615X
• Device Lot Number: 17719796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/27/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRITE TIP SHEATH
• Patient Age: 76 YR