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

Catalog Number	4002C1040
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	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left renal artery using penumbra coil 400s (pc400s).During the procedure, the physician successfully deployed and detached a pc400 using a non-penumbra microcatheter.The physician then experienced resistance and unable to advance another pc400 fully through the microcatheter.The physician continued to attempt to advance the same pc400, and consequently, the pusher wire of the pc400 became kinked and the pc400 unintentionally detached within the microcatheter.The physician attempted to use a guidewire to advance the detached pc400, however was unable to and therefore removed the microcatheter and 4f sheath, leaving the pc400 within the non-penumbra 5f catheter.The physician attempted to use a snare device to remove the pc400 from within the catheter, however was unable to, and therefore re-attempted to advance the detached pc400 using the snare device.The physician was then able to push the pc400 forward and deliver it into the target aneurysm.The procedure was completed using the same microcatheter, sheath, and 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: 7162181
• Report Number: 3005168196-2018-00011
• Device Sequence Number: 1497231
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/08/2025
• Device Catalogue Number: 4002C1040
• Device Lot Number: F75535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention