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

Catalog Number	4002C2860
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
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.This report is associated with mfr report number: 3005168196-2017-01740.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a lantern to the splenic artery through a non-penumbra catheter.Then physician then felt resistance and was unable to advance a pc400 more than approximately 30cm into the lantern; therefore, the lantern was removed with the pc400 inside.The physician then placed a new lantern and re-attempted to place the same pc400.The physician felt a strong resistance while inserting the pc400 into the lantern, but was able to successfully place the pc400.The procedure was then completed using an additional pc400 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: 6917746
• Report Number: 3005168196-2017-01741
• Device Sequence Number: 11114891
• Product Code: HCG
• UDI-Device Identifier: 00814548011981
• UDI-Public: 00814548011981
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 11/08/2024
• Device Catalogue Number: 4002C2860
• Device Lot Number: F72784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 45