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

Catalog Number	4004C0925
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
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.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid and ophthalmic artery using penumbra coil 400s (pc400s).During the procedure, one pc400 unintentionally detached while partially advanced out of the tip of the microcatheter as the physician attempted to withdraw the pc400.The physician was able to place the detached pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional clarification received on 07/20/2017 indicated that this complaint was already reported under mfr report number 3005168196-2017-01173.Therefore, please disregard this duplicate report.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6723493
• Report Number: 3005168196-2017-01232
• Device Sequence Number: 187455
• Product Code: HCG
• UDI-Device Identifier: 00814548010946
• UDI-Public: 00814548010946
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: 08/19/2022
• Device Catalogue Number: 4004C0925
• Device Lot Number: A60520
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR