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

Catalog Number	4002C1040
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a medical procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician introduced a lantern delivery microcathter (lantern) and soon after advancing the first pc400, resistance was experienced and kinked the delivery pusher; therefore, the pc 400 was removed.The procedure was successfully completed by placing ten other pc400s and the same lantern.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 76.5, 78.0 and 78.5 cm from the proximal end.The embolization coil was compressed but intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal and distal ends of the embolization coil.The distal end of the embolization coil was out of the introducer sheath.Coagulated blood was within the introducer sheath distal end.Conclusions: evaluation of the returned pc400 confirmed a kinked pusher assembly and revealed an embolization coil with offset coil winds.If the pc400 is forcefully advanced against resistance, damage such as a kink may occur.In addition, forcefully advancing against resistance may also contribute to offset coil winds.During the functional test, the pc400 was unable to be advanced out of its introducer sheath due to coagulated blood found within the pc400 introducer sheath.The lantern identified in the complaint was not returned for evaluation.The root cause of the initial resistance experienced during the procedure could not be determined.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.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8778596
• Report Number: 3005168196-2019-01344
• Device Sequence Number: 1937809
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019
• 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: 08/24/2024
• Device Catalogue Number: 4002C1040
• Device Lot Number: F71316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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