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

Catalog Number	4004C0820
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	08/27/2018
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 90.0 cm from the proximal end.The embolization coil was intact with its pusher assembly, with offset coil winds and had coagulated blood was present on the distal tip embolization coil.Resistance was encountered while advancing the pc400 within its introducer sheath.Once the distal tip of the embolization coil with coagulated blood on it was advanced out of the sheath, the coil was able to completely advance out of its sheath without an issue.While advancing the pc400 through a demonstration microcatheter, resistance was encountered as the kink in the pusher assembly was advanced through the microcatheter; however, the pc400 was able to be advanced completely through the demonstration microcatheter and out of the distal tip.Conclusions: evaluation of the returned pc400 revealed that the embolization coil winds were offset.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.The root cause of the initial resistance could not be determined.Further evaluation of the returned pc400 revealed that the pusher assembly was kinked.This kink likely occurred due to forceful advancement against resistance during procedure.During the functional test, resistance was encountered while advancing the pc400 within its introducer sheath.Once the distal tip of the embolization coil with coagulated blood on it was advanced out of the sheath, the coil was able to completely advance out of its sheath without an issue.The coagulated blood was removed by the penumbra investigator.The pc400 was then advanced through a demonstration microcatheter and out of its distal tip experiencing resistance as the pusher assembly kink was advanced through the demonstration microcatheter.The non-penumbra microcatheter identified in the complaint was not returned to penumbra 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 splenic artery using penumbra coil 400's (pc400's).During the procedure, the physician placed a non-penumbra coil in the target vessel using a non-penumbra microcatheter.While advancing a pc400 through the microcatheter, the physician experienced resistance approximately five centimeters from the microcatheter's distal tip and the pc400 was unable to advance any further.Therefore, the physician retracted the pc400 into its introducer sheath and attempted to advance it in saline.However, the physician experienced resistance again after advancing three loops of the pc400 out of its introducer sheath.The procedure was completed using a new pc400, additional coils and the same microcatheter.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: 7908330
• Report Number: 3005168196-2018-01903
• Device Sequence Number: 1625034
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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
• Report Date (Section B): 08/28/2018
• 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: 05/02/2026
• Device Catalogue Number: 4004C0820
• Device Lot Number: F83251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005