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

Catalog Number	4002C1660
Medical Device Problem Codes	Separation Failure (2547); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned embolization coil was detached and its proximal constraint sphere was intact on its proximal end.Conclusions: evaluation of the returned detachment handle revealed the funnel hole had been widened.This damage may have been a result of forcefully inserting the pusher assembly into the funnel hole.If this hole is widened the proximal end of the pusher assembly will not seat properly and likely contribute to difficulty detaching the embolization coil.Evaluation of the returned pc400 coil revealed it was detached and its proximal constraint sphere was intact.The pusher returned with this complaint was a non-penumbra pusher assembly.The pusher assembly associated with this coil was not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra detachment handles are inspected during incoming inspection by quality.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 numbers: 3005168196-2018-00681, 3005168196-2018-00682.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right femoral artery using penumbra coils 400 (pc400¿s) and a penumbra coil 400 detachment handle (handle).During the procedure, the physician experienced difficulty while attempting to advance a pc400 through a px slim delivery microcatheter (px slim).After reaching the target vessel, the physician used the handle to detach the pc400.Upon removal of the px slim, the physician noticed that the pc400 returned with the px slim and that the pc400 was not detached.The procedure was ended at that 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: 7396121
• Report Number: 3005168196-2018-00680
• Device Sequence Number: 16291722
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

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: 04/19/2024
• Device Catalogue Number: 4002C1660
• Device Lot Number: F69030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1