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

Model Number	RBY4C0315-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-01085, 3005168196-2021-01087, 3005168196-2021-01088, 3005168196-2021-01089, 3005168196-2021-01090, 3005168196-2021-01091.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the common iliac artery using ruby coils, a non-penumbra microcatheter, a diagnostic catheter, and a guidewire.During the procedure, the physician successfully implanted a ruby coil (f101571) in the target vessel.It was noted that resistance was encountered while advancing the ruby coil.The physician then attempted to advance a new ruby coil (f94874) through the microcatheter; however, resistance was encountered, and the ruby coil was removed.While advancing the next ruby coil (f101967) through the microcatheter, the physician experienced resistance but was able to successfully implant the ruby coil in the target vessel.Afterwards, the physician attempted to advance another ruby coil (f100571) through the microcatheter; however, resistance was encountered again, and the ruby coil was removed.While advancing the next two ruby coils (f101967 and f98624), the physician experienced resistance but was able to successfully implant the two ruby coils in the target vessel.It was reported that all the resistance was encountered while advancing the ruby coils around a curve.Then, the physician advanced a ruby coil (f99601) through the microcatheter, and when trying to advance the ruby coil around a curve, the physician experienced resistance.Subsequently, the physician decided to retract the ruby coil.However, while retracting the ruby coil, the physician experienced resistance, and the ruby coil unintentionally detached in the microcatheter.The physician then pushed the detached ruby coil through the microcatheter with the pusher assembly.However, while retracting the ruby coil pusher assembly, part of the ruby coil started to come back with the pusher assembly.It was reported that the ruby coil seemed to be wedged inside of the microcatheter and began to unravel.The physician then attempted to push the detached ruby coil using a non-penumbra wire; however, it was also unsuccessful.Subsequently, the physician used a snare device to remove approximately two thirds of the ruby coil.It was reported that the ruby coil became more unraveled while snaring and that one third of the ruby coil was left in the target vessel in a good location.The procedure ended at this point.There was no report of an adverse effect to the patient.
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 numbers: 1.3005168196-2021-01085, 2.3005168196-2021-01087, 3.3005168196-2021-01088, 4.3005168196-2021-01089, 5.3005168196-2021-01090, 6.3005168196-2021-01091.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11845848
• Report Number: 3005168196-2021-01086
• Device Sequence Number: 3660923
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY4C0315-B
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F94874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005