MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400422X

Device Problem Crack (1135)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82222609 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, a 4mm x 22cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was found to be cracked during a balloon inflation to 10 atmospheres (atm). As a result, the balloon was immediately deflated and the device was replaced with another 4mm x 22cm cordis balloon catheter to complete the procedure. There was no reported injury to the patient. This was during a procedure to treat a 70% stenosis in the superficial femoral artery (sfa) in which the powerflex pro pta balloon catheter was used for pre-dilation of the lesion. There was no calcification or tortuosity to the target vessel and the lesion was not a chronic total occlusion (cto). There was no difficulty removing the product from the hoop, protective balloon cover, the stylet, or any of the sterile packaging components. The device maintained negative pressure during preparation and an unknown inflation device was prepped with bayer contrast at a 1:1 contrast to saline ratio. The same, unknown inflation device was used successfully with other devices during the procedure. There was no resistance or friction experienced as the balloon entered the patient. There was no difficulty advancing the balloon catheter through the vessel, no difficulty crossing the lesion, and the device was never in an acute bend. The crack was visualized by evidence of an outflow of contrast agent form the device; however, the device did not separate as a result of the damage and was removed in one piece. Additionally, there was a noticeable drop in atmospheres upon the crack to the device. The device will be returned for evaluation.

• Brand Name: POWERFLEXPRO 4MM22CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13996566
• MDR Text Key: 291238801
• Report Number: 9616099-2022-05510
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4400422X
• Device Catalogue Number: 4400422X
• Device Lot Number: 82222609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/04/2022 Patient Sequence Number: 1

Treatment

4MM X 22CM CORDIS BALLOON CATHETER; BAYER CONTRAST; UNKNOWN INFLATION DEVICE