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

Catalog Number	RBY4C0835
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The stretch resistance wire (sr wire) was fractured, the embolization coil was detached from its pusher assembly, and the proximal constraint sphere was inside the distal detachment tip (ddt).The introducer sheath had blood inside.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured and the embolization coil was detached from its pusher assembly.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur and result in the embolization coil detaching from its pusher assembly.Further evaluation of the returned ruby coil revealed that the introducer sheath had blood inside.If continuous flush is not used during the procedure, it is likely that blood may enter the sheath.If blood coagulates on the device, it may contribute to resistance when advancing or retracting the device.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
The patient was undergoing a coil embolization procedure in the left subclavian artery using ruby coils.During the procedure, the physician attempted to place a ruby coil within the patient, however, the ruby coil was the wrong size and was therefore removed.After being retracted out of the microcatheter, the ruby coil broke off from its pusher assembly while it was being re-sheathed.The procedure was completed using a new ruby coil.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: 7827310
• Report Number: 3005168196-2018-01704
• Device Sequence Number: 16527918
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018
• 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: 07/12/2025
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F78175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 82
• Date Report Sent to FDA: 01/01/2005