MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0820
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed five pc400s using a non-penumbra microcatheter.The physician then felt resistance while advancing a pc400 through the middle of its introducer sheath and, therefore, the pc400 was removed.The procedure was then completed using two new pc400s.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.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The pull wire was completely retracted out its pusher assembly.The embolization coil was detached from its pusher assembly.Offset coil winds were present on the distal end of the embolization coil.Conclusions: evaluation of the returned pc400 revealed a fractured pusher assembly, the pull wire was retracted out of the pusher assembly and the embolization coil was detached.None of this damage was reported in the complaint.Therefore, this damage was likely incidental to the reported complaint and may have occurred post-procedure or during packaging for return to penumbra.Further evaluation revealed offset coil winds.This may have occurred as a result of advancing the device against the reported resistance.The returned damage prevented the returned device from being functionally tested; therefore, the root cause of the reported difficulty advancing could not be determined.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the reported advancement issue through the middle of the introducer sheath.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8635865
• Report Number: 3005168196-2019-01016
• Device Sequence Number: 2091004
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 04/23/2019
• 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: 09/17/2024
• Device Catalogue Number: 4004C0820
• Device Lot Number: F71656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 60
• Date Report Sent to FDA: 01/01/2005