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

Catalog Number	4002C1040
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
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 had offset coil winds.The device was kinked approximately 5.0 and 141.0 cm from the proximal end of the pusher assembly.The device was bent approximately 16.0, 54.0, 73.0, 90.0, and 107.0 cm from the proximal end of the pusher assembly.The introducer sheath was ovalized approximately 6.0 cm from the distal tip.The pc400 was returned unsheathed and coagulated blood was present inside the introducer sheath.The introducer sheath was flushed of coagulated blood and was reloaded on the pc400.The pc400 was attempted to be advanced through its introducer sheath and resistance was encountered at the ovalized point on the introducer sheath.The device was unable to be advanced further.Conclusions: evaluation of the returned pc400 confirmed an ovalization on the introducer sheath and a device with offset coil winds.If the rhv is over-tightened over the introducer sheath or if the introducer sheath is forcefully manipulated while inserting it into the parent device, damage such as an ovalized introducer sheath may occur.If the introducer sheath is damaged and the device is subsequently advanced, resistance may be experienced and damage such as offset coil winds may occur.During functional testing the pc400 was able to able be advanced through the introducer sheath until the ovalized point.The device was unable to be advanced past this point.Further evaluation revealed kinks and bends along the length of the device.If the device is forcefully advanced while experiencing resistance, damage such as kinks and bends may occur.Based on the return condition, some of the kinks and bends are likely incidental to the complaint, and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed two pc400s using a lantern delivery microcatheter (lantern).The physician then was unable to advance another pc400 out of its introducer sheath and into the lantern and, therefore, the pc400 was removed.It was reported that the tip of the introducer sheath was kinked, and there was a slight distortion in the coil.The procedure was then completed using new pc400s and the same lantern.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: 8006832
• Report Number: 3005168196-2018-02118
• Device Sequence Number: 11109343
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018
• 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: 05/09/2026
• Device Catalogue Number: 4002C1040
• Device Lot Number: F83388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/25/2018
• 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