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

Model Number	M5IVL5060
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the subject device is anticipated but has not yet begun.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.The root cause for the reported detached balloon or catheter component and balloon loss of pressure could not be determined with the limited information available.
Event or Problem Description
A shockwave m5 peripheral lithotripsy (ivl) device was used to treat a lesion in the superficial femoral artery (sfa).The shockwave m5 peripheral lithotripsy (ivl) device showed a balloon loss of pressure at the second cycle of pulses.The physician then started to pull the catheter out and, upon removal, the physician encountered resistance and the ivl catheter got trapped into the introducer sheath causing part of the ivl balloon to break off.A portion of the ivl balloon remained in the artery of the patient, the physician elected not to treat/remove the detached component due to the critical condition of the patient.As of the date of this report, no patient sequelae have been reported.
Additional Manufacturer Narrative
The ivl balloon catheter was received for investigation and damage to the balloon and catheter was confirmed.Approximately 3cm.Of the distal portion of the ivl catheter was not returned and is reported to still remain in the patient.The balloon was observed to be torn and a portion of the device broke off.As of the date of this report, no patient sequelae has been reported and the patient has not returned for a routine follow up and is continuing to be monitored.The cause for the reported balloon loss of pressure and subsequent detachment of balloon components could possibly be attributed to calcium within the patient's anatomy causing difficulties to remove the device upon withdrawal.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: 12937176
• Report Number: 3015053858-2021-00024
• Device Sequence Number: 4805997
• Product Code: PPN
• UDI-Device Identifier: 00195451000157
• UDI-Public: (01)00195451000157(17)230131(10)P210125E
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: CE 595604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 01/31/2023
• Device Model Number: M5IVL5060
• Device Catalogue Number: M5IVL5060
• Device Lot Number: P210125E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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: 0.014 ASAHI GUIDEWIRE; TERUMO 6F SHEATH
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male