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

Model Number	4006C0408
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	09/14/2019
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 using penumbra coil 400s (pc400s) and px slim delivery microcatheter (px slim).During the procedure, while advancing a pc400 through the px slim the physician experienced resistance and decided to retract the coil.However, during retraction, the physician noticed that the pc400 had unintentionally detached inside the px slim.Therefore, the microcatheter containing the detached pc400 was removed and the pc400 was flushed out.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact and wrinkled on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 5.0 cm from its proximal end.The pc400 stretch resistance wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.The proximal constraint sphere and pull wire were inside the distal detachment tip (ddt).There was no visible damage to the introducer sheath.Conclusions: evaluation of the returned pc400 revealed that the sr wire was fractured, and the embolization coil was detached from its pusher assembly.If the pc400 is manipulated with resistance, damage such as a sr wire fracture may occur.This will result in the embolization coil detaching from its pusher assembly.The px slim identified in the complaint was not returned for evaluation.The root cause of the resistance could not be determined.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9510985
• Report Number: 3005168196-2019-02379
• Device Sequence Number: 366326
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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): 11/29/2019
• 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: 08/29/2026
• Device Model Number: 4006C0408
• Device Catalogue Number: 4006C0408
• Device Lot Number: F85596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005