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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who was reported to be having chest pain underwent a percutaneous coronary intervention (pci) procedure to treat a calcified de novo lesion in the left anterior descending (lad) artery.Access to the lesion was obtained via femoral approach.Prior to the procedure, the patient was put on heparin and sedation medications.Then a rotational atherectomy was performed to help break down the calcium followed by pre-dilatation using a non-compliant (nc) angioplasty balloon.Then a shockwave c2 coronary intravascular lithotripsy (ivl) balloon was advanced towards the lesion and after delivering 40 pulses on the 2nd inflation at 4 atms, the balloon would not hold pressure.The physician deflated the balloon and pulled the catheter back to the guide catheter where it was met with resistance.After the ivl was removed, it was found that half of the balloon material was missing but the rest of the catheter was intact.Angiogram showed the lad was without flow and wire access was lost.The physician attempted to rewire the native lad however, it was unsuccessful.Since the patient already had a graft to the distal lad due to previous multiple bypass surgeries, one of the bypasses is feeding off into the lad so no surgical intervention was provided at the time.After a stay in the cath lab holding area, the patient was transferred to the intensive care unit (icu) and subsequently discharged to home with no clinical sequelae.The physician did not perform any intervention but might attempt to implant stent and pin the balloon fragment against the vessel wall at a later date.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The device was returned with the balloon and tip missing.During the investigation, the reported balloon detachment was confirmed however, the cause of the balloon rupture could not be definitively determined based on the returned components.Based upon the investigation observations, the balloon possibly had a radial tear which prevented it from fully deflating and during removal, it somehow got stuck either at the sheath entrance or in the vessel.Excess force was likely used to remove the device which was the origin of the balloon and inner member to separate.A review of the manufacturing and test documentation did not reveal any issues with the manufacturing of the device.The device passed all 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.

• 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 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 16376074
• Report Number: 3015053858-2023-00005
• Device Sequence Number: 15034620
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)240531(10)A220502D
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A220502D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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: GUIDE CATHETER - UNKNOW MANUFACTURER; NON-COMPLIANT BALLOON CATHETER - UNKNOWN MANUFACTU; ROTATIONAL ATHERECTOMY DEVICE - UNKNOWN MANUFACTUR
• Outcome Attributed to Adverse Event: Hospitalization; Other; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American