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

Model Number	RBY2C4060-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 pelvic arteriovenous fistula (avf) using ruby coils and a non-penumbra microcatheter.During the procedure, the physician successfully placed four ruby coils in the target vessel using the microcatheter and then advanced another ruby coil.Subsequently, while retracting the ruby coil through the microcatheter to reposition it, the physician encountered resistance.It was reported that since the ruby coil could only move forward, the physician continued advancing it against resistance and was able to successfully place the ruby coil in the target vessel.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and separated approximately 0.4 cm apart on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and not returned for evaluation.The pull wire was retracted from the capture feature of the distal detachment tip (ddt) and extended distal to the ddt.Conclusions: evaluation of the returned ruby coil pusher assembly confirmed that the embolization coil was detached from the pusher assembly due to the broken pet lock.If the pet lock is broken and retracted, the pull wire may retract from the ddt and allow the embolization coil to detached from its pusher assembly.The detached embolization coil was implanted and non-penumbra microcatheter was not returned for evaluation.Therefore, the root cause of the resistance experienced during the procedure was unable to be determined.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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9451227
• Report Number: 3005168196-2019-02261
• Device Sequence Number: 2972778
• Product Code: HCG
• UDI-Device Identifier: 00814548019437
• UDI-Public: 00814548019437
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019
• 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: RBY2C4060-B
• Device Catalogue Number: RBY2C4060
• Device Lot Number: F91024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 88
• Date Report Sent to FDA: 01/01/2005