MAUDE Adverse Event Report: GALIL MEDICAL, LTD MRI SEEDNET GOLD CONSOLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH2033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Swelling (2091); Urinary Retention (2119)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is derived from a literature article titled "focal salvage mr imaging guided cryoablation for localized prostate cancer recurrence after radiotherapy: 12-month follow-up." joyce g.R.Bomers, phd, christiaan g.Overduin, phd, sjoerd f.M.Jenniskens, md, erik b.Cornel, md, phd, emile n.J.T.Van lin, md, phd, j.P.Michiel sedelaar, md, phd, and jurgen j.Futterer, md, phd.J vasc interv radiol 2020; 31:35 to 41.Https://doi.Org/10.1016/j.Jvir.2019.07.001.Date of publication: jan 2020 - defaulted to first day of the month, 01 jan 2020.Additional pro code: ocl.
Event or Problem Description
It was reported that, in a literature article, three prostate cancer patients treated with cryoablation with mri-seednet (galil medical) experienced serious adverse events of urethral stricture, myocardial infarction and prostate swelling.The literature paper titled: "focal salvage mr imaging guided cryoablation for localized prostate cancer recurrence after radiotherapy: 12-month follow-up" by bomers et.Al.Describes a retrospective, single-centre review of 62 patients with prostate cancer treated with mr-guided cryoablation.Adverse events were classified according to the clavien and sir classification system.The article described the following adverse events: one patient developed a urethral stricture 6 months later, which was surgically treated (clavien grade 3b, sir class c).Another patient was hospitalized for 17 days because they experienced a myocardial infarction the day after the cryoablation.Although it is not clear that the myocardial infarction was related to the cryoablation procedure, it was defined as a clavien grade 4a/sir class d complication.Eight other patients had acute urinary retention.In the eight patient, placement of afoley catheter was not possible owing to prostate swelling, and a temporary suprapubic catheter was placed (clavien grade 3a/sir class c).The classification system used in this article noted that any adverse event above clavien grade 3a or sir grade c required intervention to prevent permanent damage.No device malfunctions were reported in this article.
Additional Manufacturer Narrative
As reported in the initial: this complaint is derived from a literature article titled "focal salvage mr imaging guided cryoablation for localized prostate cancer recurrence after radiotherapy: 12-month follow-up." joyce g.R.Bomers, phd, christiaan g.Overduin, phd, sjoerd f.M.Jenniskens, md, erik b.Cornel, md, phd, emile n.J.T.Van lin, md, phd, j.P.Michiel sedelaar, md, phd, and jurgen j.Futterer, md, phd.J vasc interv radiol 2020; 31:35 to 41.Https://doi.Org/10.1016/j.Jvir.2019.07.001 date of publication: jan 2020 - defaulted to first day of the month, 01 jan 2020 d2: additional pro code: ocl h3 other text : literature event, no return required.
Event or Problem Description
This complaint is derived from a literature article titled "focal salvage mr imaging guided cryoablation for localized prostate cancer recurrence after radiotherapy: 12-month follow-up." cryoablation with mri guidance was performed using galil medical's mri-seednet system on 62 patients with local recurrence of prostate cancer (pca) after radiotherapy between may 2011 and december 2017.The article reported three serious events as follows: one patient developed a urethral stricture 6 months later, which was surgically treated (clavien grade 3b, sir class c).Another patient was hospitalized for 17 days because they experienced a myocardial infarction the day after the cryoablation.This patient had a medical history of cardiac disease and had undergone cardiovascular interventions before.Although it is not clear that the myocardial infarction was related to the cryoablation procedure, it was defined as a clavien grade 4a/sir class d complication.In the last patient, placement of a foley catheter was not possible owing to prostate swelling, and a temporary suprapubic catheter was placed (clavien grade 3a/sir class c).No device malfunctions were reported.

• Brand Name: MRI SEEDNET GOLD CONSOLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL, LTD; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10101330
• Report Number: 2134265-2020-07203
• Device Sequence Number: 14116905
• Product Code: GEH
• UDI-Device Identifier: 07290104830914
• UDI-Public: 07290104830914
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K021261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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 Model Number: FPRCH2033
• Device Catalogue Number: FPRCH2033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention