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

Catalog Number	4004C0720
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was detached from the pusher assembly, the pull wire protruded distally out of the distal detachment tip (ddt), and the proximal constraint sphere was present inside the ddt.The embolization coil was detached and, therefore, the pc400 could not be functionally tested for tracking through a microcatheter.Conclusions: evaluation of the returned pc400 revealed a detached embolization coil with the proximal constraint sphere still present inside the distal detachment tip (ddt).This is likely the result of a stretch resistant (sr) wire fracture.Sr wire fractures typically occur due to retracting the embolization coil against resistance.Further investigation revealed the pull wire was protruding distally.Since this pull wire was still inside the capture feature, this damage is likely a result of forcefully advancing the device against resistance.Since the coil was reportedly successfully removed from the microcatheter and the detachment was not mentioned, this damage was likely incidental.The embolization coil was not returned for evaluation and, therefore, the root cause of this complaint could not be determined.The non-penumbra microcatheter was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400's (pc400's).It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician advanced a non-penumbra guide catheter towards the right iia, then advanced a non-penumbra microcatheter through it and placed four initial pc400's.While attempting to advance a new pc400 through the microcatheter, the physician experienced resistance after advancing the coil midway through the microcatheter and was unable to advance the coil further.Therefore, the microcatheter containing the pc400 was removed and the procedure was completed using the same guide catheter and three additional coils.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: 7139833
• Report Number: 3005168196-2017-02254
• Device Sequence Number: 13780641
• Product Code: HCG
• UDI-Device Identifier: 00814548010915
• UDI-Public: 00814548010915
• 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): 11/23/2017

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: 12/03/2024
• Device Catalogue Number: 4004C0720
• Device Lot Number: F73003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1