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

Model Number	RBY2C0435-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This report is associated with mfr report number: 3005168196-2020-01660.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils and non-penumbra microcatheter.During the procedure, while inserting a ruby coil into the rotating hemostasis valve (rhv), the physician experienced resistance, but, was able to advance the coil through the microcatheter under continuous flush.The physician then decided to remove the ruby coil to reposition microcatheter; however, while retracting the ruby coil, the physician experienced resistance and the ruby coil unintentionally detached inside of the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the coil was flushed out.Next, the physician inserted the same microcatheter and advanced a new ruby coil; however, resistance was encountered again, and the ruby coil was unable to advance any further out of the microcatheter.Subsequently, while attempting to re-sheath the ruby coil, the physician experienced resistance and the ruby coil unintentionally detached with half of the coil in the iliac artery and the remaining half of the ruby coil was in the microcatheter.The physician attempted to remove the microcatheter; however, half of the ruby coil was left hanging out of the vessel.Therefore, the physician used a snare device to remove the detached ruby coil.The procedure was completed using other coils.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10652769
• Report Number: 3005168196-2020-01661
• Device Sequence Number: 3871294
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2020
• Report Date (Section F): 01/01/2005

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 Model Number: RBY2C0435-A
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F97183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005