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

Catalog Number	4002C3260
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type i endoleak of aaa using penumbra coils 400 (pc400¿s).During the procedure, while attempting to advance the first pc400 through a non-penumbra microcatheter, the pc400 became stuck approximately one centimeter from the distal tip of the microcatheter; therefore, it was removed and inspected.The pc400 was then re-advanced into the microcatheter; however, the pc400 became stuck again at the same position.Therefore, the pc400 was removed and the procedure was completed using another pc400, six smart coils, a non-penumbra coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and the introducer sheath had coagulated blood inside.Conclusions: evaluation of the returned pc400 revealed that the introducer sheath had coagulated blood inside.During the functional test the pc400 could not be advance through a demonstration microcatheter due to the coagulated blood inside the introducer sheath.Therefore, the root cause of the reported issue of the coil becoming stuck inside the microcatheter could not be determined.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7473574
• Report Number: 3005168196-2018-00891
• Device Sequence Number: 10791582
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 04/03/2018
• Report Date (Section F): 01/01/2005

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: 01/21/2025
• Device Catalogue Number: 4002C3260
• Device Lot Number: F73932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005