MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRELUDE SNAP¿; SPLITTABLE SHEATH INTRODUCER

Catalog Number	PLS-1010.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the investigation is complete.
Event or Problem Description
The account alleges that during a crt-d implantation procedure the physician attempted to puncture the subclavian vein several times without success.Representation with contrast medium and further attempts followed.The artery was hit several times.The patient bled from the mouth, was intubated, artificially ventilated, resuscitated and transferred to the surgical operating room in an unstable state.No further patient condition was communicated.
Event or Problem Description
The account alleges that during a cardiac resynchronization therapy defibrillator (crt-d) implant procedure, the physician experienced some difficulty in accessing the patient's subclavian vein.During several attempts to access the vein, bleed back was verified by the attending physician.A venogram was taken to identify the targeted anatomy and landmarks with no success.The patient's artery was unintentionally pierced several times during access attempts.The patient's condition deteriorated throughout the procedure and the account alleges that the patient had to be intubated, artificially ventilated, resuscitated and transferred to a surgical suite in unstable condition.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.Corrected info for b.5: has been updated.

• Brand Name: PRELUDE SNAP¿
• Common Device Name: SPLITTABLE SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 9972582
• Report Number: 2529252-2020-00007
• Device Sequence Number: 19557627
• Product Code: DYB
• UDI-Device Identifier: 00884450251560
• UDI-Public: 00884450251560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: PLS-1010.5
• Device Lot Number: Q1599358
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention