MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR

Model Number	25000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884)
Date of Event	11/08/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
User facility reported that there were no reported issues with the lithotripter unit at the time of treatment on (b)(6) 2019.The patient received 3000 shockwaves for the treatment.Energy started at level 1 and was gradually ramped up to level 7.It was noted that most of the shockwaves were released at levels 5 and 6.Level 7 shockwaves were released in only a limited amount.The delivery rate of the shockwaves was 120 per minute.Our service technician performed an inspection of the unit on 11/18/2019 and, per his findings: all measured values were found within manufacture specifications per modulith slx-f2 manual.No issues were found upon evaluation.Pf stone test passed.System is operational in accordance with manufacturer's specifications, and equipment was returned to healthtronics.Although hematomas are a known side effect of lithotripsy, which is addressed in our ifu, the cause of the event is most likely related to the patient's pre-condition.
Event or Problem Description
Allegedly, following an extracorporeal shock wave lithotripsy procedure at (b)(6) svc.In (b)(6) on (b)(6) 2019, the patient reported to the hospital that evening.The patient was hemodynamically unstable.The patient was transfused with 7 units of blood and given vasopressors.Another 8 units of blood were transfused.Cat scan revealed very large intra- and retroperitoneal hematoma of the right kidney.Within an undisclosed time frame the patient went into renal failure and was placed on dialysis.Soon to follow the patient developed differential intravascular coagulopathy and the family made the decision to terminate his vital functions on sunday, (b)(6) 2019.The patient had a medical history that consisted of morbid obesity (5'8" tall (b)(6) lbs), hypertension, cirrhosis, a platelet count of 58,000, and a heart valve replacement.
Additional Manufacturer Narrative
Submitting supplemental report to correct original submission as a 5 day report to a 30 day report.

• Brand Name: MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR
• Common Device Name: LITHOTRIPTOR
• Manufacturer (Section D): STORZ MEDICAL AG; untereseestrasse 47; kreuzlingen ch-8280, ; SZ
• MDR Report Key: 9345162
• Report Number: 9613347-2019-00109
• Device Sequence Number: 2157065
• Product Code: LNS
• UDI-Device Identifier: 07630039100230
• UDI-Public: 7630039100230
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25000
• Device Catalogue Number: 25000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 58 YR
• Patient Weight: 110