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

Catalog Number	4002C1660
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
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 splenic artery using penumbra coil 400s (pc400).During the procedure, the physician successfully placed a pod4 and a pc400 in the target vessel using a non-penumbra microcatheter.The physician then experienced resistance while attempting to advance a new pc400 within its introducer sheath and, therefore, it was removed.The procedure was completed using a new pc400 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 the penumbra coil 400s (pc400) pusher assembly.The embolization coil was intact with the pusher assembly.Offset coil winds were present on the proximal end of the embolization coil.Dried blood was on the distal end of the embolization coil and within the introducer sheath distal tip.Conclusions: evaluation of the returned pc400 revealed dried blood within the introducer sheath and offset coil winds on the proximal end of the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing, resistance was experienced while attempting to advance the pc400 within the introducer sheath due to the dried blood.The dried blood was cleared from the introducer sheath and the pc400 was then able to advance out of its introducer sheath and through a demonstration lantern without an issue.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.Penumbra coils 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8865878
• Report Number: 3005168196-2019-01547
• Device Sequence Number: 2534708
• 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: 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: 06/19/2026
• Device Catalogue Number: 4002C1660
• Device Lot Number: F84196
• 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: 09/05/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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