MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM; INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2IVL3012
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported device separation was confirmed however, the balloon loss of pressure was unable to be confirmed because the distal portion of the device was not returned.Based on the complaint description, it is possible that when the balloon was retracted back to the proximal lesion, it got entrapped by calcium.During manipulations to unstick the balloon, it ruptured and couldn't be dislodged.The ivl catheter shaft fractured while it was being removed percutaneously from the patient with the other devices.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.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.
Event or Problem Description
It was reported that during a percutaneous coronary intervention (pci) procedure, a shockwave c2 coronary lithotripsy (ivl) catheter was used to treat a de novo lesion in the left anterior descending artery (lad).Prior to the start of the pci, a non-compliant (nc) balloon was used to pre-dilate the lesion, however, the balloon ruptured.The physician decided to use a rotoblator to remove the calcium from the target vessel.Following a successful rotoblator procedure, the physician advanced the shockwave c2 coronary lithotripsy (ivl) catheter to the distal lesion.The balloon successfully delivered 30 pulses and then it was retracted back to the proximal lesion.However, the balloon became entrapped by coronary calcium despite several rounds of therapy at the site.The physician attempted to pull back the balloon, pulled double negative and attempted to wire around without success.The balloon was inflated, and it appeared to have deformed as visually observed via angiogram and ivus imaging.The physician continued to manipulate the catheter to remove the stuck balloon at which the balloon ruptured.The physician inserted a percutaneous transluminal angioplasty (pta) balloon next to the ivl balloon to remove it, but the ivl balloon couldn't be dislodged from the left main (lm).The physician used the trapping balloon technique by inserting the trapping balloon catheter inside the guide catheter to withdraw the whole system as a unit.Contrast was injected and it showed that timi1 and timi2 flows were observed.It was reported that the ivl catheter shaft fractured while it was being removed percutaneously and then the surgeon had to cut it leaving the balloon itself lodged in the lm.The patient was transferred to surgery for a coronary artery bypass to remove the remains of the ivl catheter from the lm.The patient is recovering post bypass surgery.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 17366855
• Report Number: 3015053858-2023-00047
• Device Sequence Number: 6647693
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)241031(10)A221004A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• 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): 06/29/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A221004A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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: PTA BALLOON - UNKNOWN BRAND/MANUFACTURER; ROTOBLATOR - UNKNOWN MANUFACTURER; TRAPPING BALLOON CATHETER - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female