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

Catalog Number	RBY2C1035
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
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: 3005168196-2019-01675, 3005168196-2019-01676.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed the lantern through a non-penumbra diagnostic catheter without issue.While advancing a ruby coil out of its introducer sheath and into the lantern, the physician experienced resistance.Subsequently, the ruby coil became stuck in the lantern and unintentionally detached when the physician attempted to pull it back; therefore, the ruby coil was removed by pulling the introducer sheath.The physician then advanced another ruby coil out of its introducer sheath and through the lantern.However, resistance was encountered at the tip of the lantern and when the physician attempted to retract the ruby coil, it unintentionally detached.Therefore, the lantern containing the detached ruby coil was removed.After removal, the physician noticed the lantern was kinked/ovalized three centimeters from the tip.The procedure was then completed using five other ruby coils, a new lantern, and the same diagnostic catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 6.0, and 121.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the pull wire remained in its initial position within the distal detachment tip (ddt).The proximal constraint sphere was intact with the embolization coil.Conclusions: evaluation of the first returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.If the ruby coil is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of its pull wire, allowing the embolization coil to detach.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported complaint.Evaluation of the second returned ruby coil confirmed that the embolization coil was detached from its pusher assembly and was within the hub of the returned lantern.If the ruby coil is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of its pull wire, allowing the embolization coil to detach.Evaluation of the returned lantern revealed that the distal shaft of the catheter was kinked and ovalized.If the device is forcefully manipulated at extreme angles during use, damage such as these may occur.During functional testing, resistance was experienced while attempting to advance a demonstration ruby coil through the returned lantern due to the damage on the distal shaft.The kink and ovalization on the distal shaft likely contributed to the reported resistance experienced during manipulation of the both ruby coils within the lantern during the procedure.Penumbra coils and catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2019-01675 and 3005168196-2019-01676.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8967457
• Report Number: 3005168196-2019-01674
• Device Sequence Number: 19463178
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019
• 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 Expiration Date: 08/29/2024
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F71394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005