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

Model Number	M5IVL7060
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral m5 intravascular lithotripsy (ivl) catheter was successfully used to treat the iliac artery.Following ivl, the physician attempted to post-dilate the vessel with the ivl balloon by inflating the balloon to 10 atm which subsequently ruptured at 9atm.The physician proceeded to withdraw the balloon and met resistance.Upon inspection of the balloon after successfully removing the ivl catheter, it was observed that a portion of the balloon was missing.Multiple pictures in multiple planes were taken to verify that the detached portion was not left inside the patient.It was ultimately determined that the detached portion was not left inside of the patient.As of the date of this report, no patient sequelae has been reported.
Additional Manufacturer Narrative
Based on an investigation of the returned device, the distal portion of the balloon catheter were missing and not returned.The reporting party can confirm that the detached portion of the ivl balloon was not left inside the patient as noted in the event description.The catheter was returned inside of the guidewire and was unable to be removed from the guidewire.A portion of the balloon was stretched between an emitter and a marker band.The proximal marker band was found within the proximal bond and the inner shaft appears to have shifted proximal.The reported catheter balloon detachment was confirmed.The likely cause of the reported failure cannot be determined as half of the balloon was not returned for evaluation.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.

• 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: 13536537
• Report Number: 3015053858-2022-00009
• Device Sequence Number: 17422092
• Product Code: PPN
• UDI-Device Identifier: 00195451000195
• UDI-Public: (01)00195451000195(17)230531(10)A210512N
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: M5IVL7060
• Device Catalogue Number: M5IVL7060
• Device Lot Number: A210512N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC EXPRESS STENT- 9.0X37; MUSTANG- 9.0MMX40MM; WHISPER WIRE-SIZE UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male