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

Catalog Number	RBY4C0630
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, the physician successfully deployed and detached two ruby coils in the target vessel using a non-penumbra microcatheter.The physician then experienced resistance while advancing another ruby coil through the microcatheter, and this ruby coil did not take its intended shape when it was advanced into the target location.The ruby coil was therefore retracted to be removed, and the physician reported feeling resistance while retracting.The embolization coil was reported to have unintentionally detached, and therefore the microcatheter was removed with the embolization coil inside.The procedure was subsequently completed using additional coils, a new ruby coil, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil was folded and twisted together.Conclusions: evaluation of the returned ruby coil revealed that the device was folded and twisted together.This type of damage likely occurred due to the packaging of the device for return to penumbra.Based on the returned condition of the device, the root cause of the reported issues could not be determined.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra for evaluation.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7306400
• Report Number: 3005168196-2018-00437
• Device Sequence Number: 1741445
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/02/2018

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: 12/11/2024
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F73141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR