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

Catalog Number	4002C3260
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2016
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: 3005168196-2016-01744.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) to treat pelvic arteriovenous malformations (avm's) using penumbra coil 400's (pc400's).During the procedure, the physician advanced another manufacturer's microcatheter toward the target vessel and then attempted to advance an initial pc400 through the microcatheter.While attempting to advance the pc400 through the microcatheter, the physician encountered resistance and decided to retract the coil.The physician then made another attempt to advance the pc400 through the microcatheter; however, resistance was encountered again at the same position.Therefore, the pc400 coil was removed and a new pc400 was opened.While attempting to advance the new pc400 through the microcatheter, the physician encountered resistance at the same position in the microcatheter.Therefore, both the pc400 and microcatheter were removed.Thereafter, the procedure was successfully completed using a new px slim delivery microcatheter (px slim) and new pc400's and ruby coils.It should be noted that the two original pc400's were not advanced through the px slim because the tip of those coils became damaged.It should also be noted that the physician used a rotating hemostasis valve (rhv) and maintained a continuous flush throughout the procedure.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: 6130973
• Report Number: 3005168196-2016-01743
• Device Sequence Number: 464454
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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: 09/29/2023
• Device Catalogue Number: 4002C3260
• Device Lot Number: F65895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR