MAUDE Adverse Event Report: SHOCKWAVE MEDICAL INC. SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2IVL3512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis/Thrombus (4440)
Date of Event	01/12/2022
Type of Reportable Event	Death
Event or Problem Description
A shockwave coronary c2 intravascular lithotripsy (ivl) catheter was used to treat the right coronary artery (rca) of a de novo lesion with concentric calcium.Ivus was used but could not pass.Ivus was then followed by a 2.5mm non-compliant (nc) balloon, which successfully crossed, and ivus was then successfully used.The shockwave ivl catheter was advanced but did not cross the lesion.A 2.5 nc balloon was then used with a guideliner inside a guide for additional guide support.The ivl catheter was then able to be delivered to the tightest part of the lesion; however, could not reach the most distal section.Following ivl treatment, the vessel was patent with no evidence of dissections or perforations.It was noted that the shockwave device was the last device in the patient.It was reported that the patient went into cardiac arrest necessitating resuscitation twice during the procedure, and the patient subsequently expired.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.
Additional Manufacturer Narrative
The complaint device was returned by the reporting party.Device was received in 2 pieces.Break in the shaft was located 4 cm away from the distal end of the strain relief.The break in the shaft and kinks are attributed to handling after the procedure, as the reporting party confirmed there was no damage noted during the procedure.The root cause for the reported failure of having difficulty crossing the lesion could not be confirmed, however, it was noted that the catheter was able to advance to the tightest part of the lesion but not the most distal.The cause for the catheter not being able to fully cross during the procedure is likely due to the tight lesion in the vessel.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.A review of the manufacturing and test documentation did not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.
Additional Manufacturer Narrative
The complaint device was returned by the reporting party.Device was received in 2 pieces.Break in the shaft was located 4 cm away from the distal end of the strain relief.The break in the shaft and kinks are attributed to handling after the procedure, as the reporting party confirmed there was no damage noted during the procedure.The root cause for the reported failure of having difficulty crossing the lesion could not be confirmed, however, it was noted that the catheter was able to advance to the tightest part of the lesion but not the most distal.The cause for the catheter not being able to fully cross during the procedure is likely due to the tight lesion in the vessel.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.A review of the manufacturing and test documentation did not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.
Event or Problem Description
A shockwave coronary c2 intravascular lithotripsy (ivl) catheter was used to treat the right coronary artery (rca) of a de novo lesion with concentric calcium.Ivus was used but could not pass.Ivus was then followed by a 2.5mm non-compliant (nc) balloon, which successfully crossed, and ivus was then successfully used.The shockwave ivl catheter was advanced but did not cross the lesion.A 2.5 nc balloon was then used with a guideliner inside a guide for additional guide support.The ivl catheter was then able to be delivered to the tightest part of the lesion; however, could not reach the most distal section.Following ivl treatment, the vessel was patent with no evidence of dissections or perforations.It was noted that the shockwave device was the last device in the patient.It was reported that the patient went into cardiac arrest necessitating resuscitation twice during the procedure, and the patient subsequently expired.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 13502077
• Report Number: 3015053858-2022-00007
• Device Sequence Number: 3914806
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)231031(10)A211005F
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 10/31/2023
• Device Model Number: C2IVL3512
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A211005F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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: 2.5 NC BALLOON - UNKNOWN MFGR.; 6F GUIDE - UNKNOWN MFGR.; GODZILLA GUIDELINER - MFG: BOSON SCIENTIFIC; IVUS - UNKNOWN MFGR
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male