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

Catalog Number	RBY2C0410
Medical Device Problem Codes	Split (2537); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.The distal tip of the ruby coil¿s embolization coil had offset coil winds.Conclusions: evaluation of the returned device revealed that the ruby coil was embolization coil had offset coil winds.This damage may have occurred due to forceful manipulation of the ruby coil through a damaged microcatheter or against another source of resistance.The offset coil winds likely contributed to the resistance experienced during advancement.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.The ruby coil was attempted to be advanced through a demonstration microcatheter; however, the ruby coil could not be re-sheathed due to the offset coil winds.Therefore, the ruby coil could not be functionally tested though a demonstration microcatheter.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.
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 resistance while advancing a ruby coil through a non-penumbra microcatheter, and reported that under fluoroscopy it appeared that the ruby coil distal end was split.Therefore, the microcatheter was removed with the ruby coil inside.The procedure was then completed using the same microcatheter and additional ruby coils.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: 7131738
• Report Number: 3005168196-2017-02286
• Device Sequence Number: 13815596
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: 08/08/2025
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F78624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 64