MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. STEERABLE.BALLOON CATHETER.; KYPHOTAMP

Catalog Number	ARC25SB/A
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during a vertebral augmentation, the balloon ruptured while inflating within the spine.Part of the balloon was left behind as foreign body material as the physician was not able to retrieve.The physician states that the foreign body will not migrate and that it is acceptable to leave within the patient.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a vertebral augmentation, the balloon ruptured while inflating within the spine.Part of the balloon was left behind as foreign body material as the physician was not able to retrieve.The physician states that the foreign body will not migrate and that it is acceptable to leave within the patient.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force 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.
Additional Manufacturer Narrative
An incomplete medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.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.

• Brand Name: STEERABLE.BALLOON CATHETER.
• Common Device Name: KYPHOTAMP
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 13015108
• Report Number: 1721504-2021-00084
• Device Sequence Number: 5188790
• Product Code: HRX
• UDI-Device Identifier: 00884450490891
• UDI-Public: 884450490891
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K191596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: ARC25SB/A
• Device Lot Number: H1968329
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 03/23/2022; 10/07/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/30/2022; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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
• Patient Sex: Unknown