MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO POWERFLEXPRO 6MM22CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During an interventional procedure, a tech went to take a 6mm22cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon out of sterile sleeve to use but there was difficulty removing the balloon. And it ripped off of the shaft. Another powerflex was used to complete the procedure. There was no reported patient injury. The intended procedure was a peripheral intervention. There was no damage to the packaging of the product. It was stored on the shelf outside of procedure room. There was no damage noted to the device prior to attempting to remove it. The tech grasped the hub to gently take the catheter out. There was no excessive force used. Patient details were requested but were not available. The device will be returned for analysis.

• Brand Name: POWERFLEXPRO 6MM22CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave,; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12515538
• Report Number: 9616099-2021-04890
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059647
• UDI-Public: (01)20705032059647(17)240131(10)82212751
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 4400622X
• Device Lot Number: 82212751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG