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

Catalog Number	4002C1660
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
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 in the splenic artery penumbra coil 400s (pc400s).During the procedure, the physician placed thirty seven pc400s and three non-penumbra coils in the target vessel using a lantern delivery microcatheter (lantern).Next, the physician advanced a new pc400 through the lantern, but retracted the pc400 into its introducer sheath in order to reposition it.The physician then experienced resistance just after re-advancing the pc400 within its introducer sheath; therefore, the pc400 was removed.The procedure was completed using additional pc400s, other coils and the same lantern.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 embolization coil was intact with the pusher assembly and had offset coil winds.Coagulated blood was present within the introducer sheath.During functional analysis, resistance was experienced while attempting to advance the pc400 through its introducer sheath due to the offset coil winds.Consequently, the penumbra investigator inadvertently fractured the introducer sheath near its proximal end.Conclusions: evaluation of the returned pc400 revealed offset coil winds near the proximal end of the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.These offset coil winds likely contributed to the reported resistance experienced while re-advancing the device within its introducer sheath.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8633736
• Report Number: 3005168196-2019-00996
• Device Sequence Number: 2354448
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• 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: 06/21/2024
• Device Catalogue Number: 4002C1660
• Device Lot Number: F70271
• 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: 07/08/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005