MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC PROGUIDE CHRONIC DIALYSIS CATHETER

Catalog Number DC21452419/A

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

One device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The user reported that the catheter was found to have cracked and leaked near the hub one week after placement.The catheter was replaced.

Manufacturer Narrative

One device was returned for evaluation.The device was inspected visually and microscopically.The complaint is confirmed.The root cause could not be determined.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

• Brand Name: PROGUIDE CHRONIC DIALYSIS CATHETER
• Type of Device: CHRONIC DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 5938401
• MDR Text Key: 54268268
• Report Number: 1721504-2016-00172
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: DC21452419/A
• Device Lot Number: H907014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1