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

Catalog Number	4002C2060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra coil 400s (pc400s).During the procedure, the physician advanced a pc400 approximately 45 cm out of a lantern delivery microcatheter (lantern) into the target vessel and subsequently decided to retract the pc400 to re-position it.While attempting to retract the pc400 back into the lantern, the physician realized that the coil had prematurely detached into the patient's vessel.The physician then cut the lantern and inserted a snare in order to retrieve the pc400.Subsequently, the pc400 and the lantern were removed together from the patient and the devices were no longer used in the procedure.The procedure was completed using a new lantern, two additional pc400 coils, and eight 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 at approximately 5.0 cm, 57.0 cm and 59.0 cm from the proximal end.The pusher assembly and pull wire was fractured at approximately 62.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt) and embolization coil was detached from the ddt.The embolization coil had offset coil winds.Proximal constraint sphere was attached with the proximal end of the embolization coil.Conclusions: evaluation of the returned pc400 revealed the pusher assembly and the pull wire were fractured.Further investigation revealed kinks near the fracture site.If the device is forcefully advanced against resistance, damages such as kinks may occur.If the kinked pusher assembly is further manipulated, the kink may become fractured.The fractured pusher assembly may cause the pull wire to retract from the ddt and detach the embolization coil from the pusher assembly.Based on the returned condition of the pc400 and lantern, the devices could not be functionally tested.The root cause of the reported complaint could not be determined.Further investigation revealed an additional kink near the proximal end and offset coil winds on the embolization coil.These damages were likely incidental to the complaint.Penumbra coils and catheters 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.Conclusions code 1:  4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complained.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8633217
• Report Number: 3005168196-2019-00995
• Device Sequence Number: 1858258
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• 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): 04/23/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2025
• Device Catalogue Number: 4002C2060
• Device Lot Number: F78108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005