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

Model Number	C2IVL3012
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.During investigation, it was found that the reported difficulty removing the catheter could not be replicated.Based on the reported event, when the physician attempted to pull the guiding catheter out of the lad, it was pulled deep into the left main (lm).This resulted in a dissection in the distal (lm), into the proximal lad and the circumflex (cx) arteries.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.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
A shockwave coronary lithotripsy catheter was used on a patient who underwent a percutaneous coronary intervention (pci) procedure to treat a concentric de novo lesion in the left anterior descending (lad) artery.Access to the lesion was obtained via the left femoral artery.Prior to the procedure, the lesion was pre-dilated with a 2.0 x 15mm non-compliant (nc) balloon.When the 3.0 x 12mm ivl catheter was advanced to the target vessel, the balloon would not cross the lesion.The ivl was removed, and the lesion was pre-dilated again with a 2.75 x 20mm nc balloon.Afterwards, the ivl catheter was re-inserted along with a 45cm sheath to use as a support.The guidewire was already inserted into the lad artery and the ivl catheter was inserted over that wire through the guide catheter.This time the ivl balloon was able to cross and successfully delivered 60 pulses.When the physician attempted to pull the guide catheter out of the lad, the guide catheter was pulled deep into the left main (lm).This resulted in a dissection in the distal (lm), into the proximal lad and the circumflex (cx) arteries.The pci procedure was not able to be fully completed due to dissection.The ivl treatment was able to be completed, but the stent was unable to be implanted due to the dissection that occurred while trying to remove the ivl catheter.The pci was aborted, and the patient was immediately sent to surgery.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IV) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95133
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 96054
• MDR Report Key: 15859001
• Report Number: 3015053858-2022-00067
• Device Sequence Number: 6940783
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)240531(10)0220504B
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/15/2022

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: 05/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A220504B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 0.014" GUIDEWIRE (UNKNOWN MANUFACTURER); 45 CM SHEATH (UNKNOWN MANUFAXTURER); GUIDE CATHETER (UNKNOWN MANUFACTURER); NON-COMPLIANT BALLOONS (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male