MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	E8IVL050080
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation.The investigation concluded that the reported failures of the detached balloon or loss of balloon pressure could not be confirmed as the incorrect device was returned to the manufacturer rather than the subject device.As a result of the investigation findings, the root cause of the balloon detachment and loss of pressure could not be definitively determined based on the available information and results.Additionally, the difficulty in moving the catheter over the guidewire could not be determined, as the manufacturing and test documentation showed no issues, and the device met all acceptance criteria before shipping.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.
Event or Problem Description
A shockwave e8 peripheral intravascular lithotripsy (ivl) catheter was being used to treat the left iliac artery.It was reported that during the procedure a 6mm catheter, the ivl catheter device became stuck on a spiderwire embolic protection device.Attempts to inflate the ivl balloon failed, and blood was observed in the balloon aspiration port.Efforts to remove the catheter and spiderwire were unsuccessful, leading to the device becoming lodged at the entrance of the destination sheath.Upon removal of the ivl catheter, a portion of the balloon was observed to be missing and remained in the patient.Multiple attempts to retrieve the missing balloon and spiderwire were made, but the spider basket eventually broke off.Additional information received reported that ivl pulses had not been delivered, and the balloon had ruptured or loss pressure prior to attempts to remove.The patient was converted to surgical cut down to the common femoral artery (cfa) , successfully removing the device, and the patient was discharged after following surgery with no additional patient sequelae reported.
Additional Manufacturer Narrative
This follow-up report is to remove "foreign body in the patient" in annex e because the device was successfully retrieved and not left inside the body.Therefore, annex e codes have been updated accordingly.There was no patient sequelae reported.

• Brand Name: SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE E8 PERIPHERAL 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: 21766997
• Report Number: 3015053838-2025-00057
• Device Sequence Number: 8463586
• Product Code: PPN
• UDI-Device Identifier: 00195451000577
• UDI-Public: (01)00195451000577(17)260531(10)02A240502A
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K240225
• 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): 04/03/2025

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: 05/31/2026
• Device Model Number: E8IVL050080
• Device Catalogue Number: E8IVL050080
• Device Lot Number: 02A240502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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: 6F DESTINATION SHEATH - UNKNOWN MFG; SPIDERWIRE EMBOLIC PROTECTION DEVICE - UNKNOWN MFG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male