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

Catalog Number	4006C0306
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2016
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 400 coils (pc400 coils).During the procedure, the physician delivered three coils from another manufacturer and a pc400 coil into the target vessel using another manufacturer's microcatheter.While attempting to advance a new pc400 coil through the microcatheter, the physician experienced resistance and therefore, removed the pc400 coil.The physician then removed the microcatheter from the patient and noticed that the previously removed pc400 coil had unintentionally detached and was still contained around the hub of the microcatheter.The physician indicated that he did not experience any resistance while removing the pc400 coil.Thereafter, the procedure was completed using a new pc400 coil and a new microcatheter from the other manufacturer.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was inside the hub of the non-penumbra microcatheter, detached from the pusher assembly, and had a fractured stretch resistant (sr) wire.Conclusion: evaluation of the returned devices revealed the sr wire of the pc400 was fractured and the non-penumbra microcatheter was kinked.Attempting to retract the pc400 through a kinked microcatheter may cause the sr wire to fracture, which will cause the embolization coil to detach.Pc400s are 100% functionally tested during in-process inspection.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: 5817512
• Report Number: 3005168196-2016-01030
• Device Sequence Number: 16437179
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): N
• 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): 06/22/2016

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: Physician
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 4006C0306
• Device Lot Number: F66694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2016
• Supplement Report FDA Received Date: 08/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 60