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

Model Number C2IVL2512

Device Problems Off-Label Use (1494); Material Rupture (1546)

Patient Problems Arrhythmia (1721); Ventricular Fibrillation (2130)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported failure (err88) could not be replicated; however, balloon rupture was confirmed.It is noted that this device was used to deliver pulses within a stent, which could have contributed to the balloon rupture.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 Description

A shockwave c2 coronary intravascular lithotripsy (ivl) balloon was used in a patient who underwent a percutaneous coronary intervention (pci) to treat a chronic under-expanded stent with concentric calcium in the mid left anterior descending (lad) artery.The lesion was pre-dilated with a percutaneous transluminal coronary angioplasty (ptca) non-compliant (nc) balloon.Access to the target lesion was obtained via femoral approach.When the ivl catheter was connected to the generator, the balloon was pressurized to 4 atms and with the 1st push of the button on the connector cable, error 88 was displayed.After the staff cleared the error, the balloon was able to deliver a full 20 pulses before it ruptured.Immediately, the patient experienced ventricular fibrillation (vfib).The patient was "shocked" or defibrillated with a defibrillator and the patient was converted back to intrinsic normal sinus rhythm (nsr).After the patient was defibrillated, no other intervention was needed to treat the vfib.The patient was discharged to home the following day with no clinical sequelae.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Type of Device: 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
• MDR Report Key: 15451724
• MDR Text Key: 300211719
• Report Number: 3015053858-2022-00058
• Device Sequence Number: 1
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)230731(10)A210720K
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A210720K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DEFIBRILLATOR (UNKNOWN MANUFACTURER); PTCA BALLOON CATHETER (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White