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	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was missing.Conclusions: evaluation of the returned pc400 revealed that the sr wire was fractured.If the device is forcefully retracted against resistance, damage such as an sr wire fractured may occur.Further evaluation revealed that the non-penumbra microcatheter was kinked.The root cause of this kink could not be determined, however, this kink may have contributed to the reported resistance.The pusher assembly to the pc400 was not returned to penumbra for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed multiple pc400s and other coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance another pc400 through the middle of the microcatheter and, therefore, the physician attempted to remove the pc400.While retracting, the pc400 unintentionally detached within the microcatheter.The physician then removed the microcatheter with the pc400 inside.After removal, the physician pushed the embolization coil out of the microcatheter to confirm that it was not implanted in the patient.The procedure was completed using a new microcatheter, new pc400s, and 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: 7631719
• Report Number: 3005168196-2018-01239
• Device Sequence Number: 14081462
• 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): 05/24/2018

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: 10/16/2024
• Device Catalogue Number: 4004C0720
• Device Lot Number: F72322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1