MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL LP; HCG, KRD

Model Number RBYLP0304

Device Problems Break (1069); Premature Separation (4045)

Patient Problem Perforation (2001)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5098642.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the left profunda branch using a ruby coil lp, a non-penumbra support catheter, a non-penumbra balloon stent, a non-penumbra stent, and non-penumbra sheath.During the procedure, the physician placed a balloon stent to cover a perforation of the left superficial femoral artery (sfa); however, the perforation persisted.Next, the physician performed a second angiogram at a different angled that revealed the perforation was off a small profunda branch.It was reported that the perforation was the result of a guidewire being used to deliver the sheath at the beginning of the procedure.Subsequently, prolonged balloon inflation did not resolve the perforation.Afterwards, the physician attempted to place a ruby coil lp into the left profunda perforating branch; however, it was unsuccessful as the vessel measured approximately 0.5 millimeters and access was lost to the left profunda perforating branch.Therefore, the physician decided to retract the ruby coil lp.Upon retraction, the ruby coil lp got stuck at the tip of the support catheter.Subsequently, the ruby coil lp unintentionally detached in the sfa.Therefore, the detached ruby coil lp was removed.Then, while attempting to place a stent from the proximal end of the previously placed balloon stent to the proximal end of the sfa, the physician noticed a part of the ruby coil lp was in the proximal sfa.It was reported that part of the ruby coil lp sheared off at the tip of the support catheter.Therefore, the physician placed the stent to hold part of the ruby coil lp within the wall of the sfa.The procedure was completed using three stents, two balloon stents, the same support catheter and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11380605
• MDR Text Key: 233729808
• Report Number: 3005168196-2021-00349
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021778
• UDI-Public: 00815948021778
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYLP0304
• Device Catalogue Number: RBYLP0304
• Device Lot Number: F99453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR