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

Catalog Number	RBY2C0840
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked approximately 5.0, 102.0, 103.0, and 104.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned ruby coil revealed several kinks along the length of the pusher assembly.These kinks were likely a result of forcefully handling the pusher assembly while advancing and retracting the device against resistance during multiple attempts to place the coil.The tortuous patient anatomy likely contributed to the reported resistance and damage observed on the ruby coil.The kinks in the pusher assembly prevented the ruby coil from being functionally tested.The ruby coil introducer sheath was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.It was noted that the patient anatomy was tortuous.During the procedure, the physician placed the initials coils in the target vessel using a lantern delivery microcatheter (lantern).It was reported that mid-way through the procedure, the physician decided to switch to a non-penumbra microcatheter.While attempting to place the twelfth ruby coil into the aneurysm using the new microcatheter, the physician experienced resistance and retrieved the ruby coil back into the microcatheter.The physician then repositioned the microcatheter and ruby coil several times, then attempted to push the ruby coil into the aneurysm; however, during the repositioning attempts, the physician experienced resistance and subsequently, the ruby coil pusher assembly became severely kinked; therefore, it was removed.The procedure was completed using the same microcatheter, additional ruby coils and pod coils without issues.It should be noted that there was no noted damage to the lantern after removal.The physician just wanted to use a new microcatheter because of the patient anatomy tortuosity.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: 7162834
• Report Number: 3005168196-2018-00004
• Device Sequence Number: 16478816
• Product Code: HCG
• UDI-Device Identifier: 00814548012988
• UDI-Public: 00814548012988
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: 07/05/2025
• Device Catalogue Number: RBY2C0840
• Device Lot Number: F78055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR