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

Catalog Number	RBY4C0620
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Results: the embolization coil was detached from the pusher assembly, the stretch resistant wire (sr wire) was fractured, and the embolization coil was unraveled.Conclusions: evaluation of the returned device revealed the embolization coil was detached and unraveled, the sr wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach.Since the pusher assembly and non-penumbra microcatheter were not returned for evaluation, the root cause of the initial resistance could not be determined.The unraveling of the embolization coil likely occurred during attempts to retrieve with the snare device.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician successfully placed multiple ruby coils using a non-penumbra microcatheter.A ruby coil then became stuck within the microcatheter and the physician felt resistance while attempting to retract the ruby coil.Consequently, the ruby coil broke into two pieces upon attempting to retract against resistance, leaving one piece attached to the pusher wire, and the other piece within the patient.The physician attempted to use a snare device to remove the piece ruby coil within the patient, however the ruby coil then began to unwind.The physician therefore used a second access point in the groin of the patient to remove the ruby coil using a snare device.The procedure then ended at this point because the embolization in the target location was sufficient.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7207291
• Report Number: 3005168196-2018-00187
• Device Sequence Number: 10986929
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017
• 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: Physician
• Device Expiration Date: 02/20/2024
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F68017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 05/09/2019
• 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
• Date Report Sent to FDA: 01/01/2005