PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 61925-7060 M5IVL7060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-30 for PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 61925-7060 M5IVL7060 manufactured by Shockwave Medical, Inc..

MAUDE Entry Details

• Report Number: 3010940016-2019-00004
• MDR Report Key: 8841967
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-07-30
• Date of Report: 2019-07-30
• Date of Event: 2019-07-01
• Device Manufacturer Date: 2019-02-26
• Date Added to Maude: 2019-07-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. RYAN KIRTLAND
• Manufacturer Street: 5403 BETSY ROSS DRIVE
• Manufacturer City: SANTA CLARA CA 95054
• Manufacturer Country: US
• Manufacturer Postal: 95054
• Manufacturer Phone: 4085502607
• Manufacturer G1: SHOCKWAVE MEDICAL, INC.
• Manufacturer Street: 5403 BETSY ROSS DRIVE
• Manufacturer City: SANTA CLARA CA 95054
• Manufacturer Country: US
• Manufacturer Postal Code: 95054
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Generic Name: BALLOON CATHETER
• Product Code: PPN
• Date Received: 2019-07-30
• Model Number: 61925-7060
• Catalog Number: M5IVL7060
• Lot Number: BP190226F
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SHOCKWAVE MEDICAL, INC.
• Manufacturer Address: 5403 BETSY ROSS DRIVE SANTA CLARA CA 95054 US 95054

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-30