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

Model Number	RBY4C0860-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil and a non-penumbra microcatheter.During the procedure, while advancing the ruby coil approximately 30 percent through the distal end of the microcatheter, the physician experienced resistance.Subsequently, the ruby coil would not advance further; therefore, the ruby coil was removed.The procedure was completed using two additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: offset coil winds were present throughout the embolization coil.The stretch resistance wire (sr wire) was fractured.Conclusions: evaluation of the returned ruby coil embolization coil revealed offset coil winds throughout its length and the sr wire was fractured.If the device is forcefully manipulated against resistance, damage such as this may occur.This damage was not mentioned in the reported complaint and may be incidental and may have occurred after removal of the device from the procedure.The microcatheter identified in the complaint was not returned for evaluation; therefore, the cause of the initial resistance was unable to be determined.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10044654
• Report Number: 3005168196-2020-00640
• Device Sequence Number: 11716594
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Model Number: RBY4C0860-A
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F93849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005