MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT PRELUDE SYNC RADIAL COMPRESSION BAND

Catalog Number SRB24MED

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

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account reports that after completing an angiogram procedure, a radial arterial sheath was left in place but needed to be removed before going to recovery unit.The arterial closure band was applied around the wrist for hemostasis.A syringe was then filled with 16mls of air which should have been administered via the radial band port, but the syringe was inadvertently attached to the arterial port of the sheath.The air was injected into the radial sheath.The patient claimed to be experiencing neurological problems [hand pain].The patient was admitted to the stroke unit for observation and underwent an mri and ct scan.Both were normal.The patient has been discharged to home.No permanent or lasting damage to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause is attributed to use error.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: MERIT PRELUDE SYNC RADIAL COMPRESSION BAND
• Type of Device: RADIAL COMPRESSION BAND
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan 84095
• MDR Report Key: 6801005
• MDR Text Key: 82931579
• Report Number: 1721504-2017-00163
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162988
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: SRB24MED
• Device Lot Number: H1122997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 09/08/2017
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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): Hospitalization