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

Catalog Number	4002C1245
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the coil.The distal detachment tip (ddt) was damaged and the embolization coil was detached from the pusher assembly.The embolization coil was intact with the proximal constraint ball.The embolization coil had offset coil winds on the distal section of the coil.The pc400 was fractured approximately 116.0 cm from the proximal end of the pusher assembly.Bends were present along the length of the pusher assembly.Coagulated blood was present on the embolization coil and through the introducer sheath.Conclusions: evaluation of the returned pc400 revealed a fractured device with offset coil winds and a damaged ddt.If the device is forcefully advanced against resistance, damage such as offset coil winds and a damaged ddt may occur.Offset coil winds likely contributed to the inability to advance the pc400 out of its introducer sheath.Further evaluation revealed coagulated blood on the embolization coil and the introducer sheath.If continuous flush and an rotating hemostasis valve (rhv) are not used, blood may backflow into the microcatheter and coagulate on the device.If blood is on the device, this may contribute to the inability to unsheathe the pc400 out of its introducer sheath.Additional evaluation revealed the device was fractured and bent.Based on the return condition and the reported complaint, the fracture and bends are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 felt resistance and was unable to advance a pc400 out of its introducer sheath and into the non-penumbra microcatheter.The pc400 was therefore removed, and the procedure was completed using new pc400s and the same microcatheter.It was reported that the pc400 was compressed on the distal tip of the embolization coil.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: 7852417
• Report Number: 3005168196-2018-01748
• Device Sequence Number: 11078577
• 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): 08/07/2018
• 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: 06/11/2025
• Device Catalogue Number: 4002C1245
• Device Lot Number: F77629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• 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: 08/07/2018
• Initial Report FDA Received Date: 09/06/2018
• 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