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

Model Number	RBY2C1660-A
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, the physician successfully placed ruby coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance another ruby coil, the physician experienced resistance and was unable to advance the coil out of the introducer sheath.Therefore, the ruby coil was removed.It was reported that a slit was found at the tip of the introducer sheath.The procedure was completed using new ruby coils, pod, pod packing coils (pod pc), with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Bends and kinks were present along the pusher assembly approximately 5.0, 12.0, 15.0, 62.0, 74.0, 85.0, 87.5, 91.0 and 140.0 cm from the proximal end.The pet at the mid-joint was wrinkled.The pusher assembly was punctured approximately 169.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The ddt was kinked.Offset coil winds were present throughout the embolization coil.The introducer sheath was undamaged.Conclusions: evaluation of the first returned ruby coil was unable to confirm the reported complaint.Evaluation revealed no damage on the returned introducer sheath and the pusher was advanced out of the introducer sheath tip.Further evaluation revealed pusher assembly kinks, pet damage at the pusher assembly mid-joint, the pull wire was protruding the pusher assembly lumen, a damaged pusher assembly ddt and offset coil winds along the embolization coil.If the pusher is forcefully advanced against resistance, damage such this may occur.Due to the damage on the returned device, a functional test was unable to be performed and the reported complaint was unable to be confirmed.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #1 mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2019-00851.1.Section h.Box 6.Conclusion code 1 please note that the following statement was added in section h.Box 10./11.Narrative/corrected data: 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 complaint due to the return condition.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: 8574834
• Report Number: 3005168196-2019-00851
• Device Sequence Number: 13518923
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• 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): 04/02/2019
• 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: RBY2C1660-A
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F87479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 08/07/2019; 01/14/2005
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 08/30/2019; 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005