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

Catalog Number	4002C1235
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
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 in the internal carotid artery (ica) using penumbra coil 400s (pc400s).During the procedure, a pc400 would not advance within its introducer sheath; therefore, the pc400 was removed.The procedure was completed using other coils.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 pusher assembly was kinked approximately 46.5 cm, 53.0 cm, 102.0 cm, 114.0 cm, 125.5 cm, 131.5 cm, 142.5 cm, 150.0 cm and 154.0 cm from the proximal end.The embolization coil had offset coil winds and was intact with its pusher assembly.Conclusion: evaluation of the returned pc400 revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not seated properly within the hub of the parent catheter, damage such as this may occur.This damage likely contributed to the reported inability to advance the device out of its sheath.During functional testing, the returned pc400 was able to advance in and out of its introducer sheath with minor resistance.Further evaluation revealed kinks along the pusher assembly.These damages are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils are 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: 8179419
• Report Number: 3005168196-2018-02466
• Device Sequence Number: 19237656
• Product Code: HCG
• UDI-Device Identifier: 00814548010632
• UDI-Public: 00814548010632
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018
• 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: Health Professional
• Device Expiration Date: 07/05/2022
• Device Catalogue Number: 4002C1235
• Device Lot Number: C04217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/14/2019
• 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