MAUDE Adverse Event Report: ALPHA MEDICAL INTRODUCER, CATHETER

Model Number DPX-11/G

Device Problems Use of Device Problem (1670); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This sheath was used during an implant procedure on (b)(6) 2018.A two-incision technique was preformed but the sheath got lifted and peel away was not sufficiently performed.The physician was dr.(b)(6) at (b)(6) hospital.No other information available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INTRODUCER, CATHETER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ALPHA MEDICAL
• MDR Report Key: 17527942
• MDR Text Key: 321406355
• Report Number: MW5134873
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2018

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?: No
• Device Model Number: DPX-11/G
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1