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

Catalog Number	RBY2C0740
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
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.The hospital disposed of the device.
Event or Problem Description
During preparation for a coil embolization procedure, the nurse noticed that a ruby coil embolization coil was out of its introducer sheath upon removal from the dispenser hoop.The physician then tried to push and pull the ruby coil but it was not successful.Therefore, the ruby coil was set aside and the procedure was completed using another coil.
Additional Manufacturer Narrative
Results: the pusher assembly was kinked along its length.The proximal pet lock was damaged.The pusher assembly was fractured approximately 5.0 cm from the proximal end and embolization coil was detached inside the introducer sheath.The introducer sheath was ovalized approximately 18.5 cm-19.0 cm, 27.0 cm, 40.0 cm, 46.5 cm, 53.0 cm, 75.5 cm and 78.0 cm from the proximal end of the sheath.The embolization coil had offset winds along in multiple locations within the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed the pusher assembly was fractured and the embolization coil was detached.If the ruby coil is mishandled during removal from the packaging, the pusher assembly may become fractured allowing the embolization coil to detach.This is further supported by the embolization coil being detached within the introducer sheath.Further evaluation revealed the friction lock was damaged, the pusher assembly and introducer sheath were kinked, and the embolization coil had offset coil winds.This damage was likely incidental to the reported complaint.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7611867
• Report Number: 3005168196-2018-01209
• Device Sequence Number: 123832
• Product Code: HCG
• UDI-Device Identifier: 00814548012964
• UDI-Public: 00814548012964
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018
• 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: 11/26/2025
• Device Catalogue Number: RBY2C0740
• Device Lot Number: F80754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005