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

Catalog Number	4004C1030
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the penumbra coil 400 (pc400) pusher assembly was kinked in multiple locations and fractured in multiple locations.The pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and had the proximal constraint sphere intact, and the pull wire was retracted out of the distal detachment tip (ddt).Conclusions: the returned pc400 pusher assembly was kinked and fractured due to its return packaging conditions.Due to this return packaging-related damage, the root cause of the reported resistance and unintentional detachment could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery using penumbra coil 400''s (pc400s).During the procedure, the physician advanced a non-penumbra catheter and microcatheter towards the treatment site of the target vessel.Next, the physician placed two non-penumbra coils as anchoring coils and two additional pc400''s to fill the target vessel.While attempting to advance a third pc400 through the microcatheter, the physician experienced subtle resistance around the hub of the microcatheter and subsequently, the pc400 became stuck inside the microcatheter.The physician then attempted to retract the pc400; however, upon retraction, the pc400 unintentionally detached within the microcatheter.Therefore, the physician removed the microcatheter containing the detached coil and flushed the coil out.Thereafter, the microcatheter was flushed again and used with nine additional coils to complete the procedure.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: 6836322
• Report Number: 3005168196-2017-01484
• Device Sequence Number: 1419691
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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: 03/14/2025
• Device Catalogue Number: 4004C1030
• Device Lot Number: F75029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1