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

Catalog Number	4002C1660
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 and 17.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The embolization coil was advanced out of its introducer sheath.The embolization coil winds were offset.Conclusions: evaluation of the returned device revealed that the pc400 embolization coil winds were offset.This type of damage typically occurs due to forceful advancement of the pc400 against resistance.The root cause of this initial resistance could not be determined; however, if an rhv and continuous flush are not used during advancement of the pc400, resistance during advancement may be more likely to occur.The pc400 embolization coil was returned halfway advanced out of its introducer sheath.While attempting to functionally test the returned pc400, the pc400 was unable to be re-sheathed and then advanced through a demonstration microcatheter due to the offset coil winds.The lantern mentioned in the complaint was not returned for evaluation.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 in the celiac artery using penumbra coils 400 (pc400s).During the procedure, the physician placed a non-penumbra coil in the target vessel using the trans-cell technique.After that, the physician advanced a lantern delivery microcatheter (lantern) in the target vessel and attempted to advance a pc400; however, the physician was unable to advance the pc400 out of its introducer sheath and into the lantern.Therefore, the introducer sheath containing the pc400 was removed and the procedure was completed using the same lantern, three other pc400s and two pod coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the celiac artery using penumbra coil 400s (pc400s).During the procedure, the physician placed a non-penumbra stent in the target vessel using the trans-cell technique.After that, the physician advanced a lantern delivery microcatheter (lantern) to the target vessel and attempted to advance a pc400; however, the physician was unable to advance the pc400 out of its introducer sheath and into the lantern.Therefore, the introducer sheath containing the pc400 was removed and the procedure was completed using the same lantern, three additional coils and two pod coils.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: 7104612
• Report Number: 3005168196-2017-02187
• Device Sequence Number: 16339021
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• 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,Followup
• Report Date (Section B): 11/13/2017
• 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: Physician
• Device Expiration Date: 09/25/2024
• Device Catalogue Number: 4002C1660
• Device Lot Number: F71792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/04/2019
• 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