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

Catalog Number	RBY2C1460
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
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.This report is associated with mfr report numbers: 3005168196-2019-00317; 3005168196-2019-00319.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician was unable to advance a ruby coil more than 2/3 of the way through the lantern.The ruby coil was then retracted and re-advanced, however it became stuck at the same place within the lantern.The ruby coil was then removed and the lantern was flushed.Upon advancement of another ruby coil through the lantern, the same issue occurred.This ruby coil was also removed.The physician then attempted to advance a third ruby coil through the lantern, and the same issue again occurred.The third ruby coil was then removed.The procedure was completed using other coils and the same lantern.After the procedure, the ruby coils were inspected and were found to have visible disintegration of the coil braid near the detachment zone.It was also reported that no pieces of the damaged coils were left in the patient.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance during advancement and was unable to advance a ruby coil more than 2/3 of the way through the lantern.The ruby coil was then retracted and re-advanced, however it became stuck at the same place within the lantern.It was also reported that resistance was experienced upon retraction.The ruby coil was then removed and the lantern was flushed.Upon advancement of another ruby coil through the lantern, the same issue occurred.This ruby coil was also removed.The physician then attempted to advance a third ruby coil through the lantern, and the same issue again occurred.The third ruby coil was then removed.The procedure was completed using other coils and the same lantern.After the procedure, the ruby coils were inspected and were found to have visible disintegration of the coil braid near the detachment zone.It was also reported that no pieces of the damaged coils were left in the patient.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the sales representative on 03/26/2019: describe event or problem, device code 3.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end of its pusher assembly.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned lantern revealed that the catheter shaft was ovalized.If the lantern was forcefully pinched or gripped during use, damage such as an ovalization may occur.The ovalization likely contributed to the inability to advance the ruby coils.A demonstration ruby coil was attempted to be advanced through the returned lantern and was unable to advance past the ovalization on the device.Evaluation of the first ruby coil revealed the embolization coil had offset coil winds and the sr wire was fractured.If the ruby coil is forcefully advanced against resistance, damage such as offset coil winds may occur.Further evaluation revealed a fractured sr wire.If the embolization coil was forcefully retracted through the introducer sheath friction lock, damage such as an sr wire fracture may occur.The sr wire fracture was likely incidental to the reported complaint.Evaluation of the second ruby coil revealed the pusher assembly was kinked and the embolization coil had offset coil winds.If the ruby coil is forcefully advanced against resistance, damage such as kinks and offset coil winds may occur.During functional testing, resistance was encountered while attempting to advance the ruby coil through its introducer sheath and the ruby coil could not be advanced any further.Evaluation of the third ruby coil revealed the pusher assembly was fractured and the embolization coil had offset coil winds.If the device is forcefully advanced against resistance, damage such as kinks and offset coil winds may occur.Subsequently, if the kinked pusher assembly is further manipulated, damage such as a fracture may result.Penumbra coils and catheters are visually inspection 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.This report is associated with mfr report numbers: 1.3005168196-2019-00319 2.3005168196-2019-00317 3.3005168196-2019-01251.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8362725
• Report Number: 3005168196-2019-00318
• Device Sequence Number: 16611074
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 01/23/2019
• 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 Expiration Date: 05/16/2026
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F83528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 06/13/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/17/2019; 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005