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

Catalog Number	4004C0513
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
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 hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a right pulmonary arteriovenous malformation (pavm) using penumbra coil 400's (pc400's).During the procedure, the physician advanced a non-penumbra microcatheter towards the target pavm, then deployed and detached two pc400's.While attempting to deploy a new pc400 into the pavm, the physician did not like the shape that the coil was taking and began manipulating it.After several attempts of advancing and retracting the coil, the physician noticed that the coil had unintentionally detached inside the microcatheter.Therefore, the physician attached a syringe to the back of the microcatheter and pulled negative pressure back.The microcatheter containing the pc400 was then removed.Thereafter, the microcatheter was flushed and used to complete the procedure with new pc400's.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: 6699296
• Report Number: 3005168196-2017-01128
• Device Sequence Number: 880753
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2017

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: 10/16/2024
• Device Catalogue Number: 4004C0513
• Device Lot Number: F72307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2017
• Initial Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 65