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

Catalog Number	4002C1557
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the proximal constraint sphere was not present on the embolization coil, the stretch resistant wire (sr wire) was fractured, and the embolization coil was damaged.Only the embolization coil of the pc400 was returned; the pusher assembly was not returned for evaluation.Evaluation of the returned px slim revealed a device ovalized in multiple locations.If the device is forcefully gripped or pinched, damage such as an ovalization may occur.The ovalizations may have contributed to the inability to advance the pc400.Evaluation of the returned pc400 revealed a fracture sr wire.The reported complaint mentioned resistance was experienced when advancing the device.If the pc400 became lodged with the px slim ovalizations and was subsequently retracted, resistance may have again been experienced.The fracture of an sr wire typically happens due to forcefully retracting the device against resistance.The px slim ovalizations likely contributed to the resistance advancing and retracting the pc400.Further evaluation revealed embolization coil damage.This damage was likely due to subsequent handling of the embolization coil after the sr wire became fractured.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2018-02048.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a px slim delivery microcatheter (px slim) and penumbra coil 400s (pc400s).During the procedure, the physician felt resistance while advancing a pc400 through the px slim and, consequently, the pc400 unintentionally detached within the px slim.The physician then tested the px slim by advancing a guidewire through it and confirmed that it was obstructed.The px slim was therefore removed with the pc400 inside, and the procedure was completed using a new microcatheter and new pc400s.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8242636
• Report Number: 3005168196-2019-00074
• Device Sequence Number: 1593782
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2018
• 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: 4002C1557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005