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

Catalog Number	RBY2C0312
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
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 20.0, 71.0, and 109.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly inside the introducer sheath.The introducer sheath was ovalized approximately 10.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed that the ruby coil pet lock was intact on the proximal end of the pusher assembly.If the handle is not properly seated on the proximal end of the pusher assembly prior to attempting to detach the coil, it is likely that the coil will not detach from its pusher assembly.A broken pet lock indicates that the handle was seated properly on the proximal pusher assembly during an attempt to detach the coil.Further evaluation of the returned device revealed that the introducer sheath was kinked and the sr wire was fractured.If the introducer sheath is kinked and the coil is retracted through the kinked sheath, damage such as a fractured sr wire may occur.The root cause of the kinked sheath may have been due to forceful manipulation during use.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.This report is associated with mfr report number: 3005168196-2018-00844.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using ruby coils and a ruby coil detachment handle (handle).It was noted that the patient's anatomy was tortuous.During the procedure, the physician advanced a ruby coil in the target vessel, but was unable to detach it using the handle.Therefore, the ruby coil was removed and the procedure was completed using a new ruby coil and the same handle.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7455225
• Report Number: 3005168196-2018-00843
• Device Sequence Number: 1235710
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• 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): 03/29/2018

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: Physician
• Device Expiration Date: 12/13/2025
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F81038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR