MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer address 1: tavor building 1, industrial park.
Event or Problem Description
It was reported the patient experienced tachycardia requiring resuscitation.An icesphere 1.5 cx 90 degree needle was chosen for a ganglion impar cryoneurolysis procedure.The patient was prone on the computed tomography (ct) table under moderate sedation.The icesphere needle was inserted into the ganglion impar area.The anesthesiologist administered additional pain medications prior to starting the freeze cycle.The patient became immediately tachycardic.The code team was called in and the patient was resuscitated.The procedure was cancelled.The patient is currently in the intensive care unit (icu).
Additional Manufacturer Narrative
D3: manufacturer address 1: tavor building 1, industrial park.H10: device evaluation by manufacturer: the icesphere 1.5 cx 90 degree needle was returned for analysis.Visual inspection revealed that the needle shaft was bent, and the device cable was cut.Functional testing was unable to be performed because the cable was cut.
Event or Problem Description
It was reported the patient experienced tachycardia requiring resuscitation.An icesphere 1.5 cx 90 degree needle was chosen for a ganglion impar cryoneurolysis procedure.The patient was prone on the computed tomography (ct) table under moderate sedation.The icesphere needle was inserted into the ganglion impar area.The anesthesiologist administered additional pain medications prior to starting the freeze cycle.The patient became immediately tachycardic.The code team was called in and the patient was resuscitated.The procedure was cancelled.The patient is currently in the intensive care unit (icu).

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1, yokne; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19429418
• Report Number: 2124215-2024-32306
• Device Sequence Number: 20860618
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 07/18/2025
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0032136412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: White