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

Model Number RBY4C0860-A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  Injury  

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: 3005168196-2019-02152; 3005168196-2019-02153; 3005168196-2019-02154; 3005168196-2019-02155; 3005168196-2019-02156; 3005168196-2019-02157; 3005168196-2019-02158; 3005168196-2019-02164.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils and px slim delivery microcatheters (px slims).During the procedure, the physician advanced a px slim 045 into a non-penumbra diagnostic catheter followed by an 8x60 ruby coil.However, the 8x60 ruby coil was unable to advance through the px slim 045.The 8x60 ruby coil was subsequently removed.Another 8x60 ruby coil was then advanced through the px slim 045 and the same issue occurred.Therefore, this 8x60 ruby coil was also removed.The same issue was then encountered with a third 8x60 ruby coil, and this coil was also removed.Following these events, the physician decided to remove the px slim 045 from the procedure.The physician continued the procedure using a px slim straight tip and regained access to the target vessel on the ipsilateral side.Another 8x60 ruby coil was then advanced into the px slim straight tip.While advancing the 8x60 ruby coil out of the px slim straight tip, the physician encountered resistance and reported that the 8x60 ruby coil became partially detached.The px slim straight tip was housing part of the detached coil; therefore, the physician decided to remove the devices together.However, upon removal, the 8x60 ruby coil fully detached and became implanted into the patient¿s external iliac artery.The 8x60 ruby coil was then removed using a snare device.The physician continued the procedure by advancing a px slim 090 to the target vessel, followed by an 8x35 ruby coil.The 8x35 ruby coil did not advance through the px slim 090 and the physician decided to remove the 8x35 ruby coil and px slim 090 together from the patient.Subsequently, a non-penumbra catheter (excelsior xt27) was advanced into the target vessel and was successfully used to implant two 10x35 ruby coils.Upon advancement of a 8x35 ruby coil through the non-penumbra catheter (excelsior xt27), the physician encountered difficulty and the pusher assembly of the 8x35 ruby coil broke.Despite the unintentional detachment, the 8x35 ruby coil was successfully implanted into the target vessel.The procedure was then ended.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section b.Box 5.Describe event or problem.This report is associated with mfr report numbers: 1.3005168196-2019-02152, 2.3005168196-2019-02153, 3.3005168196-2019-02154, 4.3005168196-2019-02155, 5.3005168196-2019-02156, 6.3005168196-2019-02157, 7.3005168196-2019-02158, 8.3005168196-2019-02164 h3 other text : placeholder.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils and px slim delivery microcatheters (px slims).During the procedure, the physician advanced a px slim 045 into a non-penumbra diagnostic catheter followed by an 8x60 ruby coil.However, the 8x60 ruby coil was unable to advance through the px slim 045 and resistance was experienced during both advancement and retraction.The 8x60 ruby coil was subsequently removed.Another 8x60 ruby coil was then advanced through the px slim 045 and the same issue occurred.Therefore, this 8x60 ruby coil was also removed.The same issue was then encountered with a third 8x60 ruby coil, and this coil was also removed.Following these events, the physician decided to remove the px slim 045 from the procedure.The physician continued the procedure using a px slim straight tip and regained access to the target vessel on the ipsilateral side.Another 8x60 ruby coil was then advanced into the px slim straight tip.While advancing the 8x60 ruby coil out of the px slim straight tip, the physician encountered resistance and reported that the 8x60 ruby coil became partially detached.The px slim straight tip was housing part of the detached coil; therefore, the physician decided to remove the devices together.However, upon removal, the 8x60 ruby coil fully detached and became implanted into the patient¿s external iliac artery.The 8x60 ruby coil was then removed using a snare device.The physician continued the procedure by advancing a px slim 090 to the target vessel, followed by an 8x35 ruby coil.However, the physician encountered resistance and the 8x35 ruby coil was unable to advance through the px slim 090.Therefore, the 8x35 ruby coil and px slim 090 were removed together from the patient.Subsequently, a non-penumbra catheter was advanced into the target vessel and was successfully used to implant two 10x35 ruby coils.Upon advancement of a 8x35 ruby coil through the non-penumbra catheter, the physician encountered resistance and the pusher assembly of the 8x35 ruby coil broke.The 8x35 ruby coil was then removed using a snare device.The procedure was then ended.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report.1.Section d.Box 4.Device expiration date.This report is associated with mfr report numbers: 1.3005168196-2019-02152; 2.3005168196-2019-02153; 3.3005168196-2019-02154; 4.3005168196-2019-02155; 5.3005168196-2019-02156; 6.3005168196-2019-02157; 7.3005168196-2019-02158; 8.3005168196-2019-02164.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9365178
• MDR Text Key: 167798222
• Report Number: 3005168196-2019-02159
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/24/2019

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
• Device Operator: Health Professional
• Device Model Number: RBY4C0860-A
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F90126
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 01/14/2005; 01/14/2005
• Supplement Dates FDA Received: 01/03/2020; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR