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

Model Number	M5PIVL7060
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.No components were found missing.Multiple kinks were noted on the catheter shaft.No other damage was noted on the catheter shaft.The inner member was broken within the balloon, distal to the distal marker band.All components were accounted for, including the marker bands and emitters.The inner member was elongated proximal and distal to the distal marker band.All of the emitters showed signs of wear as expected.There were wrinkled sections of the balloons over emitter #4 and the distal marker band.There were no tears, ruptures, or pinholes noted on the balloon, and no damage was noted on the distal tip.A shipping mandrel was inserted into the catheter from the tri-port hub.Resistance was encountered about 2 inches proximal to the distal tip while advancing the shipping mandrel, but the mandrel still went through successfully without excessive force.As the shipping mandrel exited the distal end of the inner member in the balloon, debris was pushed out, likely due to a combination of dried blood and dried saline/contrast residue.The shipping mandrel was then removed with no resistance encountered.It was attempted to insert the catheter into an introducer sheath from the distal end, but it was unable to as the inner member break did not allow for stability of the catheter to be inserted and pulled through the introducer sheath.The reported failure of device separation was confirmed, but the reported inability to track over the guidewire or through the sheath was unable to be confirmed.Due to the condition of the returned device, functional testing using a sheath could not be performed.The likely cause of the device separation and inability to remove the device from the sheath could not be determined.Shockwave medical, inc.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 shockwave medical, inc.Criteria prior to shipping.
Event or Problem Description
It was reported that a shockwave ivl (intravascular lithotripsy) m5+ peripheral catheter was used to treat a lesion in the iliac artery.After treatment, there was difficulty removing the balloon from the 7fr sheath.A detachment occurred almost all the way back in the sheath.Approximately half of the balloon was separated from the proximal balloon marker to about the third emitter.The balloon material was hanging off the distal edge of the balloon, but not completely separated.The physician was able to get all of the balloon material out of the patient.The physician removed the sheath and the ivl balloon while maintaining the wire position and a new sheath was inserted.There was difficulty removing the balloon off the wire once it was outside the body.The physician clamped a hemostat to the balloon shaft to remove the ivl catheter and pulled while the tech held the wire in position.There was no patient harm 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: 18580978
• Report Number: 3015053858-2024-00004
• Device Sequence Number: 12812873
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)241031(10)82266807
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K203365
• 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): 01/08/2024

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: 10/31/2024
• Device Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82266807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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: 300CM GRANDSLAM WIRE (ASAHI).; 7FR 25CM TEURMO PINNACLE SHEATH
• Patient Age: 75 YR
• Patient Sex: Female