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

Catalog Number	4002C0415
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
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 lumbar artery using penumbra coil 400s (pc400s).During the procedure, the physician advanced a lantern delivery microcatheter (lantern) into the target vessel and attempted to advance a pc400 through the lantern; however, resistance was encountered after advancing a loop of the pc400 out of the lantern.The physician then attempted to retract the pc400; however, resistance was encountered again.Therefore, the physician removed the lantern along with the pc400 from the patient and removed the pc400.The procedure was completed using four additional 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 50.0 cm from the proximal end.The stretch resistant wire (sr wire) was fracture and the embolization coil was detached from its pusher assembly.The distal detachment tip (ddt) had coagulated blood inside.The proximal constraint sphere was not present within the ddt.Conclusions: evaluation of the returned pc400 revealed a fractured sr wire and detached embolization coil.If the device is forcefully retracted against resistance, damage such as these may occur.The lantern identified in the complaint was not returned for evaluation; therefore, the root cause of the reported resistance could not be determined.Further evaluation of the returned pc400 revealed a pusher assembly kink.This damage was likely incidental to the reported complaint.Penumbra coils and catheters 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: 8872068
• Report Number: 3005168196-2019-01542
• Device Sequence Number: 18964244
• Product Code: HCG
• UDI-Device Identifier: 00814548013381
• UDI-Public: 00814548013381
• 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): 07/10/2019
• 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: 06/01/2024
• Device Catalogue Number: 4002C0415
• Device Lot Number: F69600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005