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

Catalog Number	4004C0615
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	06/26/2019
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.This report is associated with mfr report number: 3005168196-2019-01546.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400) and pod packing coils (pod pc).During the procedure, the physician successfully placed two pc400s in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400, the physician experienced resistance approximately 20 centimeters from the proximal end of the microcatheter.Therefore, the pc400 was removed and successfully placed a new pc400 in the vessel.The physician then attempted to advance a pod pc, however, experienced the same resistance approximately 20 centimeters from the proximal end of the microcatheter and, therefore, the pod pc and microcatheter were removed.The procedure was completed using new pod pcs and the same microcatheter.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 its pusher assembly penumbra coil 400 (pc400).The pusher assembly was kinked approximately 5.0, 11.0, 13.0, 17.0, and 22.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly was kinked.This damage was likely incidental to the reported complaint.These kinks prevented functional testing of the coil and the non-penumbra microcatheter was not returned; therefore, the root cause of resistance could not be determined.Evaluation of the returned pod pc revealed coagulated blood inside the introducer sheath.If blood enters the introducer sheath and the device is not flushed after removal from the patient, the blood may begin to coagulate inside the sheath and prevent the coil from being advanced and retracted within its introducer sheath.During the functional test, resistance was encountered while attempting to re-sheath the pod pc and it could not be retracted any further.Further evaluation of the returned pod pc revealed that the embolization coil had offset coil winds.This damage was likely incidental to the reported issue and may have occurred due to packaging the device for return with the coil advanced outside its introducer sheath.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.Therefore, root cause of the reported complaint could not be determined.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.This report is associated with mfr report number: 3005168196-2019-01546.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8879015
• Report Number: 3005168196-2019-01545
• Device Sequence Number: 18886086
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• 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: 10/29/2024
• Device Catalogue Number: 4004C0615
• Device Lot Number: F72562
• 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: 10/11/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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