MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. DOUBLE PLAY HEMOSTASIS VALVE; DOUBLE Y HEMOSTASIS VALVE

Catalog Number MAP221/A

Device Problem Fracture (1260)

Patient Problem Thrombus (2101)

Event Date 09/12/2017

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 alleges that during an aneurysm embolization the hemo map [rotator] cracked.To ensure the aneurysm was treated, the staff pressed the broken rotator together manually by hand for 20-30 minutes while the physician continued to place 3 additional coils without contrast injections for placement verification.Because of the broken rotator, the physician placed more coils than intended to make sure the patient would survive the aneurysm.After coil placement the hemo map device was replaced.During contrast injections under fluoro, to verify coil placement, the physician could see soft thrombus forming within the posterior inferior cerebral artery [pica].The account alleges that the extra coils caused the thrombus formation.The physician then administered integrelin to the patient.The physician states that "the aneurysm procedure was life threatening and with thrombus in the brain a stroke is always possible".The day after the procedure the patient was stable.No permanent damage to report.

Manufacturer Narrative

One device has been returned for evaluation.The complaint is 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.

• Brand Name: DOUBLE PLAY HEMOSTASIS VALVE
• Type of Device: DOUBLE Y HEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 94095
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 94095 ; 8012531600
• MDR Report Key: 6915898
• MDR Text Key: 88226611
• Report Number: 9616662-2017-00027
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: MAP221/A
• Device Lot Number: K945837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention