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

Catalog Number	RBY2C0430
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly of the second ruby coil evaluated.The pusher assembly was kinked in multiple locations.The embolization coil was detached from the pusher assembly and the sr wire was fractured.Conclusions: evaluation of the returned device revealed the ruby coils¿ sr wires were fractured.The microcatheter kicking out of the aneurysm during the procedure likely contributed to the fractured sr wires.Fracture of the sr wire will allow the embolization coil to detach and unravel.Further evaluation revealed the pusher assembly was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.The non-penumbra microcatheter mentioned in the complaint and the embolization coil of the second ruby coil were not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2017-00725.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician experienced difficulty repositioning the ruby coil inside the gda using a non-penumbra microcatheter because of tortuous anatomy; consequently, the microcatheter kicked out of the aneurysm and the coil broke and unraveled.The physician attempted to remove the coil with a snare device; however was unsuccessful.The physician then reinserted the same microcatheter and attempted to advance a new ruby coil to continue the embolization; however, while deploying, the microcatheter backed out again, and this ruby coil also broke and unraveled.The physician attempted to snare the broken ruby coil, however inadvertently dissected the vessel; therefore, the procedure was ended at this point and the patient was transferred to the intensive care unit (icu).As of (b)(6) 2017, the patient was considered stable and was discharged, and will undergo an additional procedure to place a stent over the partially placed ruby coil remaining inside the hepatic artery.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6563483
• Report Number: 3005168196-2017-00726
• Device Sequence Number: 16276855
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/13/2017

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: 12/25/2024
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F73368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/12/2017
• 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
• Patient Age: 58 YR