MAUDE Adverse Event Report: PALINDROME; PERMACATH

Lot Number 328317X

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2015

Event Type  malfunction  

Event Description

Permacath implanted on (b)(6) 2015; explanted on (b)(6) 2015 due to noted "pin sized hole" at dialysis center; unable to replicate leakage but catheter replaced.

• Brand Name: PALINDROME
• Type of Device: PERMACATH
• MDR Report Key: 5124164
• MDR Text Key: 27466421
• Report Number: MW5056768
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/28/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Lot Number: 328317X
• Other Device ID Number: REF#8888128450P
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR