MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC PRELUDE SHEATH INTRODUCER

Catalog Number PSI-6F-11-018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Patient Problem/Medical Problem (2688)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account reported that post percutaneous coronary intervention (pci) the physician tried to remove the sheath from the patient's radial artery and was not able to do so.The sheath appeared to be stretched but still intact.Diazemuls 5 mg, followed later by an additional 5mg to help overcome vasospasm.Sheath was wired with competitor's pci wire, which was passed through the arm and up in to the aortic arch.Dilation within the sheath with a 2.0 balloon multiple times followed by inflation proximal to sheath and attempt to retrieve all sheath material with steady tension on the balloon and the sheath.The sheath broke in the mid-section leaving part of sheath inside the radial artery.Despite multiple attempts via retained guidewire it was not possible to remove the residual sheath material.Hemostasis was controlled with a 4f sheath and a tr band with the wire left in place.A consultant vascular surgeon was called and came directly up to the lab where it was decided that the patient would required surgery under local anesthesia to remove the sheath.The patient is doing well post-operation.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The product was examined visually by photograph.The complaint is confirmed.No definitive root cause could be determined.However, it is likely that significant force was applied to the device during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: PRELUDE SHEATH INTRODUCER
• Type of Device: SHEATH INTRODUCER
• 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, csqp ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6592918
• MDR Text Key: 76009675
• Report Number: 1721504-2017-00128
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K070159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: PSI-6F-11-018
• Device Lot Number: H1086775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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
• Patient Outcome(s): Required Intervention