MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	M5PIVL8060
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.Therefore, a physical examination has not been performed.Evaluation of the subject device is anticipated but has not yet begun.After the device is received and investigation is completed, a supplemental report will be submitted.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 m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac arteries.The physician was unable to remove the device through the 7f introducer sheath.The physician had to remove the introducer sheath at the same time as the catheter.Due to a hole in the 7f sheath, bleeding occurred.As the 7f sheath also had to be removed and the physician had a.014" wire in the vessel, bleeding and hematoma occurred around the puncture site.As of the date of this report, the treatment of the hematoma is unknown and the status of the patient is unknown.
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The ivl catheter was received with the 7f introducer sheath.The reported inability to remove the ivl catheter from the 7f sheath could not be confirmed.Shockwave was unable to replicate the insertion and removal difficulties through the 7fr introducer sheath returned with the ivl catheter.Additionally, all components of the ivl catheter were found intact.The cause of the reported bleeding and hematoma could not be definitively determined based on the available information and investigation performed.As of the date of this final report, there has been no additional patient sequalae reported.

• Brand Name: SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE M5+ 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: 19397778
• Report Number: 3015053858-2024-00053
• Device Sequence Number: 12701142
• Product Code: PPN
• UDI-Device Identifier: 00195451000287
• UDI-Public: (01)00195451000287(17)250531(10)01A240314A
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K203365
• 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): 07/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: M5PIVL8060
• Device Catalogue Number: M5PIVL8060
• Device Lot Number: 01A240314A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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: .014" GUIDEWIRE - UNKNOWN MANUFACTURER.; INTRODUCER SHEATH - UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown