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

Model Number	RBY2C0630-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
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 number: 3005168196-2020-00336.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod, ruby coils, a pod packing coil (pod pc) and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the physician successfully implanted a pod coil in the target vessel using the microcatheter.While advancing a ruby coil through the microcatheter, the ruby coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the ruby coil was flushed out.The physician then implanted a new ruby coil in the target vessel using the microcatheter.Next, while inserting a pod pc into the hub of the microcatheter, the pod pc unintentionally detached in the hub of the microcatheter; therefore, the microcatheter containing the detached pod pc was removed and the pod pc was flushed out.The procedure was completed using two non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil stretch resistance wire (sr wire) was fractured and the proximal constraint sphere was detached from the embolization coil.The embolization coil had offset coil winds.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil was detached from the pusher assembly due to the sr wire fracture.If the ruby coil is forcefully retracted against resistance, damage such as a sr wire fracture may occur, and embolization coil will detach from the pusher assembly.No other devices associated with the complaint was returned for evaluation; therefore, the root cause of the resistance was unable to be determined.Further evaluation of the device revealed offset coil winds on the embolization coil.These offset coil winds were likely incidental to the complaint and could have occurred during packaging for return to penumbra.Evaluation of the returned pod pc confirmed that the embolization coil was detached from the pusher assembly and revealed that the sr wire was fractured, and embolization coil was unraveled.If the device is forcefully retracted against resistance, damages such as these may occur.No other devices associated with the complaint was returned for evaluation; therefore, the root cause of the complaint was unable to be determined.Penumbra coils are 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 number: 1.3005168196-2020-00336.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9825900
• Report Number: 3005168196-2020-00335
• Device Sequence Number: 1827961
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): Y
• Initial Reporter Country: GT
• 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): 02/20/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C0630-A
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F91697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005