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

Model Number	C2IVL3012
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A shockwave c2 coronary lithotripsy (ivl) device was used to treat the left anterior descending (lad) coronary artery.During the initiation of the shockwave ivl therapy procedure, flashes of blue light were observed in the shockwave hub, in the direction of the indeflator, and the assisting nurse reported received electric shocks in her hand/fingers, which was painful and caused a numb/strange feeling in her fingers lasting for 3 hours.The assisting nurse had no injury to her fingers and did not require any treatment and the condition of her fingers was reported to have resolved without further incident.A new ivl catheter was opened and the ivl procedure was successfully completed.
Additional Manufacturer Narrative
The complaint device was returned by the reporting party.Based on an evaluation of the returned device, the reported failure "flashes of blue light observed in the shockwave hub" was confirmed evidenced by red and black wire insulation damage at the proximal end of the hypotube.The root cause for the symptoms the assisting nurse reportedly experienced could not be determined with the information available.The complaint device was tested by shockwave personnel and could not confirm that the device was providing an electric shock.The cause for the reported sparking in the hub is attributed to the wire insulation possibly being accidentally scratched/nicked during the manufacturing process, exposing the bare wires, and creating a spark gap in the dual-port hub.Sparking in the hub is a known device malfunction; even though the broken/damaged wires could cause current leakage and visual flashing/sparking, the leakage is contained within a plastic hub and does not pose any risk of electrical shock to the user and/or patient.No instances of patient harm have been reported/confirmed to be caused due to this malfunction.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.

• 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: 13089698
• Report Number: 3015053858-2021-00033
• Device Sequence Number: 5320488
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)230430(10)A210401C
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A210401C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown