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

Catalog Number	4004C0710
Medical Device Problem Codes	Failure to Fold (1255); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
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 middle cerebral artery (mca) using penumbra coil 400s (pc400s).During the procedure, the physician encountered resistance while advancing the pc400 into the aneurysm.It was also reported that the pc400 would not adjust to the intended shape within the aneurysm.The pc400 was therefore removed and was not used in the procedure.The procedure was completed using another pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the follow-up #01 report and are being corrected on this follow-up #02 mfr report.Results: the pet lock was intact on the proximal end of the penumbra coil 400 pusher assembly.The pusher assembly was kinked at approximately 19.0 and 101.5 cm from the proximal end.The proximal constraint sphere and pull wire were within the pusher assembly distal detachment tip (ddt).The stretch resistant (sr) wire was fractured and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned pc400 pusher assembly was unable to confirm the reported inability to take its intended shape.The embolization coil was not returned for testing.Further evaluation revealed that the embolization coil was detached due to a sr wire fracture and the pusher assembly was kinked.This damage was likely incidental to the reported complaint.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.Conclusions code 1: 4316 the investigation findings do not lead to a clear conclusion about the coil''s inability to take its intended shape.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 pusher assembly.The pusher assembly was kinked at approximately 19.0 and 101.5 cm from the proximal end.The proximal constraint sphere and pull wire were within the pusher assembly distal detachment tip (ddt).The stretch resistant (sr) wire was fractured and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned pc400 pusher assembly revealed that the embolization coil was detached due to an sr wire fracture.If the device is forcefully retracted against resistance, the sr wire may become fractured, allowing the embolization coil to detach from the pusher assembly.The embolization coil was not returned for evaluation; therefore, the reported complaint could not be confirmed.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the reported complaint.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8925605
• Report Number: 3005168196-2019-01614
• Device Sequence Number: 2128434
• Product Code: HCG
• UDI-Device Identifier: 00814548011691
• UDI-Public: 00814548011691
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 07/24/2019
• 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 Catalogue Number: 4004C0710
• Device Lot Number: F86700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 01/14/2005
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/12/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005