MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE® SHORT SHEATH; SHORT INTRODUCER SHEATH

Catalog Number PSS-7F-4MT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.

Event Description

The account alleges that after the physician removed the sheath, it was noted that the sheaths black marker tip had detached.The clinical staff looked for the foreign body under fluoroscopy and was able to successfully identify the marker tip within the patient's arteriovenous fistula.The physician deployed a covered stent to successfully pin the foreign body in place, preventing foreign body migration.The patient tolerated the procedure well, with no additional consequences to report.

Manufacturer Narrative

The suspect device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: PRELUDE® SHORT SHEATH
• Type of Device: SHORT INTRODUCER SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15510034
• MDR Text Key: 300889571
• Report Number: 1721504-2022-00083
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884450015322
• UDI-Public: 884450015322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PSS-7F-4MT
• Device Lot Number: H2456589
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Treatment: GUIDEWIRE; INTERVENTIONAL BALLOON
• Patient Outcome(s): Required Intervention