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

Catalog Number	4006C0406
Medical Device Problem Codes	Entrapment of Device (1212); Migration or Expulsion of Device (1395); Unraveled Material (1664)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/15/2016
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.Device was partially implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the major aorto-pulmonary collateral artery (mapca) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed and detached eight pc400 coils into the aneurysm.Upon removing the microcatheter from the parent catheter, the angiogram revealed that the last pc400 coil was pushed out from the collateral circulation and into the parent vessel by blood flow.The physician attempted to retrieve the pc400 coil using a snare device; however, the pc400 coil became unraveled.The physician then made multiple attempts to retrieve the unraveled coil filaments from the patient's body using the snare device; however, on the third attempt, the pc400 coil filaments were unintentionally cut off.The remaining portion of the coil filaments were left in the body but not visible under fluoroscopy.Taking into consideration how much time had passed, the physician decided to end the procedure at this point.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: 5664050
• Report Number: 3005168196-2016-00680
• Device Sequence Number: 261562
• Product Code: HCG
• UDI-Device Identifier: 00814548011899
• UDI-Public: 00814548011899
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2016

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: 03/31/2021
• Device Catalogue Number: 4006C0406
• Device Lot Number: F33956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Initial Report FDA Received Date: 05/18/2016
• 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
• Patient Age: 2 YR