MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	L6IVL120030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and is ongoing.The cause of the arterial rupture, abdominal hemorrhage, and loss of blood could not be definitively determined based on the information currently available.While there was no report of ivl catheter malfunction, a review of the returned device showed evidence of damage.It was reported that the physician was aware that the 12mm ivl catheter was 40-50% oversized for the patient's vessel segment and that the use was off-label.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 l6 peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac arteries.The vessel was pre-dilated with a 3.5mm x 100 mm sterling balloon followed by a 4.0 sterling balloon.During ivl treatment, the 12mm ivl catheter was placed in the portion of the vessel that measured 7-8mm, causing the artery to rupture.Abdominal hemorrhage and loss of blood was also noted.The patient required cpr (cardiopulmonary resuscitation) and a blood transfusion.The physician used covered stents to repair the rupture.The patient was doing fine following the procedure.While there was no report of ivl catheter malfunction, it was reported that the physician was aware that the 12mm ivl catheter was 40-50% oversized for the patient's vessel segment and that the use was off-label.
Additional Manufacturer Narrative
The subject device was returned for investigation and the distal marker band was noted to be missing.The returned catheter was found to be damaged and detached at the inner member and outer shaft.The cause of the device getting stuck could not be definitely determined, but review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.Based on the reported information.There was no report of ivl catheter malfunction nor any device detachment that occurred.The device was completely removed from the patient following ivl treatment.It was reported that the physician was aware that the 12mm ivl catheter was 40-50% oversized for the patient's vessel segment and that the use was off-label.

• Brand Name: SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE L6 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: 20355904
• Report Number: 3015053858-2024-00113
• Device Sequence Number: 12555446
• Product Code: PPN
• UDI-Device Identifier: 00195451000416
• UDI-Public: (01)00195451000416(17)250731(10)07B230705A
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K240954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 07/31/2025
• Device Model Number: L6IVL120030
• Device Catalogue Number: L6IVL120030
• Device Lot Number: 07B230705A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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: Required Intervention; Disability
• Patient Age: 72 YR
• Patient Sex: Male