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)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 24.0 and 106.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.The introducer sheath was loaded backwards on the pusher assembly.Conclusions: evaluation of the pc400 revealed that the embolization coil had offset coil winds along its length.If the device is forcefully advanced or retracted against resistance, damage such as this may occur.The offset coil winds may have contributed to the coil¿s inability to exit the distal tip of the microcatheter.Further evaluation of the pc400 revealed that the introducer sheath was loaded backwards onto the pusher assembly.This damage likely occurred post-procedure and had no effect on the reported issue.While attempting properly sheath the returned pc400, resistance was encountered as the mid-joint on the pusher assembly was being advanced through the introducer sheath friction lock.The pc400 was unable to be properly sheathed and could not be functionally tested through a demonstration microcatheter.The non-penumbra microcatheter 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 in the right internal iliac artery using penumbra coils 400 (pc400¿s).It was noted that the patient¿s anatomy was slightly calcified.During the procedure, while attempting to advance a pc400 through a non-penumbra microcatheter, the physician experienced resistance at the distal tip of the microcatheter and the pc400 became stuck and could not be pushed out; therefore, it was removed.The procedure was completed using eight other pc400¿s and the same microcatheter.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: 7496670
• Report Number: 3005168196-2018-00953
• Device Sequence Number: 18881212
• 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): 04/09/2018

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: 11/18/2025
• Device Catalogue Number: 4004C1030
• Device Lot Number: F80627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1