MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL

Catalog Number	RBY4C0315
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2018
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 in multiple locations.The embolization coil was detached from its pusher assembly and the stretch resistant wire (sr wire) was fractured.The introducer sheath was ovalized approximately 3.5 cm from the distal tip and the sheath had blood inside.Conclusions: evaluation of the returned ruby coil revealed the sr wire was fractured.If the ruby coil is forcefully manipulated against resistance, damage such as this may occur.Further evaluation revealed the introducer sheath was ovalized.If the introducer sheath is forcefully gripped or pinched during use, ovalizations may result.The ovalization in the introducer sheath likely contributed to the resistance and eventual fracture of the sr wire.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra for evaluation.Penumbra catheters 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 noticed that a ruby coil was detached while attempting to advance it out of its introducer sheath.Therefore, the ruby coil was set aside and the procedure was completed using other ruby coils and a non-penumbra microcatheter.

• Brand Name: RUBY COIL
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7456340
• Report Number: 3005168196-2018-00834
• Device Sequence Number: 1481902
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/26/2018

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: 01/15/2026
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F81417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• 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