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

Model Number	M5IVL6060
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event, in the presence of nodular calcium, the balloon was pulsed while inflated to 10atms, which is outside the procedural instructions for use, likely contributing to the event.The physician was well aware that increasing the pressure can lead to un-predictability within the balloon, but elected to proceed anyway.The device mentioned in the complaint was discarded and not available for investigation.Hence a physical inspection of the device was not possible.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet all release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.
Event or Problem Description
A m5 6.0x60 shockwave ivl catheter was used to treat the distal superficial femoral artery (sfa) with 150 pulses at 4 atm in the presence of nodular calcium.After that, the pressure was increased to 10 atms, which is beyond the recommended treatment pressure of 4 atm of the label (off-label), and pulsed at which time the balloon ruptured.The physician was well aware that increasing the pressure can lead to un-predictability within the balloon, but elected to proceed anyway.Upon removal of the device, the balloon portion got stuck at the end of the destination sheath.The physician attempted multiple methods to remove the catheter, and during one of those attempts, the balloon sheared off the catheter.A snare was used in an attempt to snare and remove the balloon portion, but only a portion of the detached balloon could be snared.A covered stent was implanted to stent the detached balloon against the vessel wall and out of the lumen.The physician believe that the combination of nodular calcium and pulsing at 10atm's lead to a complete tear in the material of the balloon that would not allow it to re-wrap properly to be removed from body.There have been no patient sequelae reported as a result of this event.

• 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
• MDR Report Key: 11905519
• Report Number: 3015053858-2021-00008
• Device Sequence Number: 4572067
• Product Code: PPN
• UDI-Device Identifier: M732M5IVL60600
• UDI-Public: M732M5IVL60600
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 10/31/2022
• Device Model Number: M5IVL6060
• Device Catalogue Number: M5IVL6060
• Device Lot Number: P201027B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention