MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER

Model Number	E8IVL040080
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported difficulties to remove the ivl catheter, loss of balloon pressure, and catheter detachment were confirmed based on the condition of the returned device.It is possible that the balloon was not fully deflated and therefore made it more difficult to withdraw through the treatment site.Then, the force used to remove the device could have caused it to detach at the distal end and may have been stuck near existing iliac stents.However, it could not be definitively confirmed with the information available.Per the ifu, it is noted: "do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury." a series of kinks were noted on the outer shaft along with radial ruptures.The cause of the kinks is unknown.Based on the reported information, investigation observations, and the condition of the returned device, the cause of the device becoming stuck could not be definitively determined.Balloon ruptures are a known failure mode with a low probability of occurrence.Contributing factors include patient calcium, damage caused when the balloon wall comes into close contact with the device emitters, likely causes include (a) an irregular calcium lesion capable of compressing the balloon wall into close proximity with the emitter(s) and/or (b) an incompletely inflated balloon.The shockwave intravascular lithotripsy (ivl) system with the shockwave e8 peripheral ivl catheter generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure not to exceed 4 atm during ivl treatment, and 4 atm for post dilatation.The pressure used for the ivl balloon catheter is much lower than other balloon catheters used in percutaneous coronary intervention (pci), thus the risk associated with loss of balloon pressure during ivl catheter use is negligible.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation.The physician attributes the event to multiple factors - patient iliac anatomy, existing iliac stents, and extreme arterial calcification - and the physician suspects loss of ivl balloon pressure caused the balloon to become entrapped in calcified plaque with the guidewire adhering to the ivl balloon.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
It was reported that a shockwave e8 peripheral intravascular lithotripsy (ivl) catheter was used during a procedure to treat the superficial femoral artery (sfa)/popliteal lesion.200 ivl pulses were delivered, and the treatment of the popliteal lesion was successfully completed.A 6fr guide catheter was used during the procedure, and the ivl device had been tracked through pre-existing iliac stents to treat the popliteal lesion.During shockwave ivl device removal attempts, it was reported that the ivl balloon became caught in the ansel sheath.The ivl balloon had been fully deflated prior to device removal attempts.Excessive force was applied during manipulation.The physician tried to pull the ivl catheter through the up-and-over sheath but encountered tremendous resistance; and the ivl catheter subsequently became lodged in the artery.Continued pulling caused the shaft of the ivl catheter to break proximal to the ivl balloon.Further pulling and manipulation of the sheath caused the sheath to shear and break off in the iliac region as well.The distal portion of the ivl catheter including the entire ivl balloon (approximately 80 mm) detached and remained in situ in the iliac region of the patient.Multiple attempts over two hours to snare the retained fragment with multiple snares were unsuccessful.The physician subsequently determined the best option for the patient is to perform an urgent axillary-femoral bypass.The physician attributes the event to multiple factors - patient iliac anatomy, existing iliac stents, and extreme arterial calcification - and the physician suspects loss of ivl balloon pressure caused the balloon to become entrapped in calcified plaque with the guidewire adhering to the ivl balloon.The patient is still hospitalized and stable with no immediate vascular harm identified, and current care is focused on unrelated gastrointestinal comorbidities that are unrelated to the ivl procedure.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL 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: 24329326
• Report Number: 3015053858-2026-00014
• Device Sequence Number: 21281830
• Product Code: PPN
• UDI-Device Identifier: 00195451000560
• UDI-Public: (01)00195451000560(17)270630(10)01A250603A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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 Model Number: E8IVL040080
• Device Catalogue Number: E8IVL040080
• Device Lot Number: 01A250603A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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: CXI 014X150 SUPPORT CATHETER - COOK MEDICAL; GLIDEWIRE ADVANTAGE - TERUMO; SERENITY BALLOON - COOK MEDICAL; SERRANATOR - CAGENT VASCULAR; SHEATH, FLEXOR ANSEL GUILDING 6FR 55CM - MCKESSON
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 80 YR
• Patient Sex: Unknown