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

Catalog Number	RBY4C0315
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached, stretch resistant wire (sr wire) was fractured, and coil winds were stretched.Conclusions: evaluation of the first returned ruby coil revealed the introducer sheath was ovalized at multiple locations along its length.This damage caused resistance when advancing or retracting the pusher assembly through the sheath and likely contributed to the resistance experienced during the procedure.These ovalizations also prevented the embolization coil from being fully re-sheathed.During functional testing, the returned coil was re-sheathed inside a demonstration sheath and was advanced through a demonstration catheter without issue.Evaluation of the second returned ruby coil revealed a detached embolization coil with a fractured sr wire.This damage is typically a result of forcefully retracting the device against resistance.The pusher assembly and non-penumbra catheter used in the complaint were not returned for evaluation.The root cause of the resistance could not be determined.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.This report is associated with mfr report number: 3005168196-2018-00784.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a branch of the inferior mesenteric artery (ima) using ruby coils.During the procedure, the physician successfully placed multiple ruby coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance two ruby coils through the microcatheter, and therefore the ruby coils were removed.The procedure was completed using new ruby coils and the same microcatheter.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: 7434506
• Report Number: 3005168196-2018-00785
• Device Sequence Number: 1314963
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/19/2018

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: 12/11/2025
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F80980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79