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

Catalog Number	4002C1245
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.The stretch resistance wire (sr wire) was wrapped around the distal detachment tip (ddt) and the embolization coil had several offset coil winds.The introducer sheath was kinked approximately 10.0 cm from the distal tip.Conclusions: evaluation of the returned pc400 revealed the embolization coil winds were offset in several locations.If the coil is forcefully advanced against resistance the coil winds can become offset and contribute to additional resistance when attempting to advance the device.The lantern identified in the procedure was not returned for evaluation; therefore, the root cause of the initial resistance could not be determined.Further evaluation revealed the introducer sheath was kinked.This damage was likely incidental and may have occurred during packaging for return to penumbra.During the functional test, resistance was encountered while attempting to advance the pc400 out of its introducer sheath and the pc400 could not be advanced any further.The introducer sheath kink may have contributed to the difficulty advancing experienced during functional testing.In addition, the embolization winds were compressed causing there to be slack in the sr wire.Subsequently attempting to advance the device may cause the sr wire to wrap around the ddt.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2018-01921.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using penumbra coil 400s (pc400s).During the procedure, the physician experienced resistance while advancing a pc400 through a lantern delivery microcatheter (lantern); therefore the pc400 and lantern were removed from the patient.The procedure was completed using new pc400s and a new lantern.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: 7920467
• Report Number: 3005168196-2018-01920
• Device Sequence Number: 1937164
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018
• 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: 09/25/2024
• Device Catalogue Number: 4002C1245
• Device Lot Number: F71788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• 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: 08/31/2018
• Initial Report FDA Received Date: 09/28/2018
• 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