MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA RUBY COIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Lot Number RBYLP0304

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 11/17/2020

Event Type  malfunction  

Event Description

There appeared to be a perforation of the left sfa, and this was covered with a 6.0mm vbx.However, the perforation persisted, and a second injection at a different angle showed the perf was off a small profunda branch, presumably the result of the glide wire being used for the sheath delivery at the start of the case.4.Prolonged balloon inflation did not resolve the perforation.An attempt to coil the left profunda perforating branch was unsuccessful as it was an approximately 0.5mm vessel.The coil was retrieved.5.Attention was now turned to residual disease in the left sfa.A 6.5x120mm supera was placed from the proximal end of the vbx back to the proximal sfa.As this was being deployed, a remnant of the coil was noted in the proximal sfa.It had sheared off at the tip of the trailblazer delivery catheter.The supera stented the coil remnant against the wall of the sfa, this will endothelialize without clinical consequence.Fda safety report id # (b)(4).

• Brand Name: PENUMBRA RUBY COIL
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; alameda, CA 94502
• MDR Report Key: 11108394
• MDR Text Key: 225279749
• Report Number: MW5098642
• Device Sequence Number: 2
• Product Code: HCG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: RBYLP0304
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR