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

Catalog Number	RBY2C0305
Medical Device Problem Codes	Unraveled Material (1664); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
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 in the left hepatic artery using a ruby coil.During the procedure, while advancing a ruby coil into the target vessel using a non-penumbra microcatheter, the physician decided to retract it for repositioning.However, while retracting the ruby coil, no resistance was experienced and the ruby coil unintentionally detached inside the patient.Therefore, the physician used a snare device to remove the detached ruby coil.While retracting, the ruby coil began to unravel.It was reported that the physician successfully pulled and removed the entire ruby coil from the patient.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned; however, on (b)(6)2019 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) 2.Section h.Box 3: device returned to manufacturer)? 3.Section h.Box 3: device evaluated by manufacturer? additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy) results: the embolization coil was completely unraveled.The proximal constraint sphere and distal solder were not present on either ends of the embolization coil.Conclusions: evaluation of the returned ruby coil revealed a detached and fractured embolization coil.The proximal constraint sphere and distal solder was not present on either ends of the embolization coil.No other devices associated with the complaint were returned for evaluation.Based on the returned condition, the root cause of the reported complaint could not 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported advancement issue through the non-penumbra microcatheter.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: 9126506
• Report Number: 3005168196-2019-01828
• Device Sequence Number: 2527981
• Product Code: HCG
• UDI-Device Identifier: 00814548012810
• UDI-Public: 00814548012810
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2025
• Device Catalogue Number: RBY2C0305
• Device Lot Number: F75921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005