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

Catalog Number	4002C1245
Medical Device Problem Codes	Collapse (1099); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
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 fractured approximately 5.0 cm and kinked approximately 69.0 cm from the proximal end.The pull wire was completely retracted out of the distal detachment tip (ddt).The embolization coil was detached from its pusher assembly inside its introducer sheath.The embolization coil was advanced partially out of the distal tip of the introducer sheath, had offset coil winds and coagulated blood was present inside the sheath.Conclusions: evaluation of the returned pc400 revealed the pusher assembly was kinked and the embolization coil had offset coil winds.These damages are likely a result of forcefully advancing against resistance.The non-penumbra microcatheter used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation revealed the pusher assembly was fractured.If the pusher assembly is forcefully manipulated outside of the patient body the pusher assembly may become fractured.This will likely cause the pull wire to retract from the distal detachment tip (ddt), allowing the embolization coil to detach.This fracture and coil detachment were likely incidental and occurred post-procedure as they were not mentioned in the complaint report.Blood was coagulated within the introducer sheath preventing the returned pc400 from being functionally tested.If continuous flush is not used, blood may backflow into the sheath and may contribute to resistance experienced during the procedure.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 using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed seven pc400s using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance another pc400 through the middle of the microcatheter and, therefore, the pc400 was removed.It was reported that the embolization coil was distorted and compressed at the tip.The procedure was then completed using a new pc400 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: 7890320
• Report Number: 3005168196-2018-01836
• Device Sequence Number: 13918759
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• 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): 08/20/2018
• 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: 04/15/2026
• Device Catalogue Number: 4002C1245
• Device Lot Number: F82873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• 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: 08/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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