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

Catalog Number	RBY2C1460
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 and 12.5 cm from the proximal end.The pusher assembly was fractured approximately 14.5 cm from the proximal end and the pull wire was completely retracted out of the pusher assembly.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned ruby coil confirmed the pusher assembly was fractured.If the device is forcefully retracted out of its packaging hoop at extreme angles, damage such as a kink may occur.If the kink is subsequently mishandled, damage such as a fracture may occur.Further evaluation of the returned device revealed that the pull wire was completely retracted out of its pusher assembly.Retracting the pull wire from the distal detachment tip (ddt) will effectively detach the embolization coil.The pull wire is likely the wire that was observed hanging between the two part of the broken pusher assembly.Penumbra coils 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.
Event or Problem Description
During preparation for a coil embolization procedure, the physician found that the pusher assembly of the ruby coil was broken upon removal from the packaging.In addition, there was a wire hanging between the two parts of the broken pusher assembly.The damage to the ruby coil was found prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed using a new ruby coil.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7520184
• Report Number: 3005168196-2018-00975
• Device Sequence Number: 1176212
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/16/2018

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: 04/12/2025
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F75626
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1