MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO INFLATION DEVICE.BASIXCOMPAK¿.; SYRINGE, BALLOON INFLATION, EXEMPT

Catalog Number	IN4330/K
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that a hemostasis valve that is packaged with the inflation device kit detached during contrast injections.The physician decided to exchange the hemostasis device rather than pop the valve back on and continue the case.Usual pressures were used through hemostasis device via the acist injection device during deployment within the left coronary network.During the replacement of the hemostasis valve, the guide catheter via guidewire was reinserted into the patient resulting in a perforation of a coronary artery that led to required medical intervention due to the patients cad.
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is 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.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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: INFLATION DEVICE.BASIXCOMPAK¿.
• Common Device Name: SYRINGE, BALLOON INFLATION, EXEMPT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17347804
• Report Number: 3011642792-2023-00049
• Device Sequence Number: 12272384
• Product Code: PTM
• UDI-Device Identifier: 00884450638323
• UDI-Public: 884450638323
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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: 09/25/2025
• Device Catalogue Number: IN4330/K
• Device Lot Number: I2514273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 08/07/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/14/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDECATHETER; GUIDEWIRE; WIRE INTRODUCER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown