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

Catalog Number	RBY2C0320
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	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with the pusher assembly and had offset coil winds near its distal end.Conclusions: evaluation of the returned device revealed dried blood throughout the introducer sheath and offset coil winds near the distal tip of the embolization coil.The offset coil winds may have occurred due to attempts to withdraw the embolization coil into an introducer sheath occluded with blood.Once the blood was flushed out by a penumbra investigator, the ruby coil was advanced through its introducer sheath and a demonstration microcatheter without issue.The tortuous patient anatomy may have contributed to the resistance experienced during the procedure.The pusher assembly kinks were likely incidental and may have occurred during packaging for return to penumbra.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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 to treat a variocele using ruby coils.It was noted that patient's anatomy was tortuous but not extreme.During the procedure, while attempting to advance a ruby coil through a lantern delivery microcatheter (lantern), the physician experienced resistance and the ruby coil would only advance half way in a lantern.Therefore, the ruby coil was removed and the procedure was completed using another ruby coil and the same lantern.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: 7277533
• Report Number: 3005168196-2018-00350
• Device Sequence Number: 2379086
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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: 05/17/2025
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F77208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 87