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

Catalog Number	RBY2C0420
Medical Device Problem Codes	Detachment Of Device Component (1104); Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastroduodenal artery bleed using ruby coils.During the procedure, the physician deployed and detached the initial ruby coil in the target vessel using a non-penumbra microcatheter.After that, the physician advanced a ruby coil out of the non-penumbra microcatheter and into the target vessel but decided to retract the coil for repositioning.While retracting the ruby coil, the physician did not mention resistance; however, the ruby coil unintentionally detached leaving its distal end in the common hepatic artery.Therefore, the physician attempted to use a snare device to remove the detached ruby coil; however, the physician was unable to remove the ruby coil and the ruby coil distal end was left in the common hepatic artery.The physician decided to end the procedure at this point.It was reported that the distal end of the ruby coil in the hepatic artery was considered insignificant.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: 6843635
• Report Number: 3005168196-2017-01523
• Device Sequence Number: 13629910
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/27/2025
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F75244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention