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

Catalog Number 4002C1040

Device Problems Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pc400 was fractured approximately 127.0 cm from the proximal end.The pc400 was kinked approximately 5.0 cm from the proximal end.The embolization coil was detached within the introducer sheath and its proximal constraint sphere is intact.Conclusions: evaluation of the returned pc400 revealed the device was fractured and the embolization coil was detached.This damage was likely a result of a kink that worsened to fracture.The kink was likely a result of the reported advancement against resistance.If a kinked catheter is continually manipulated or otherwise mishandled the kink may become fractured.If the pusher assembly becomes fractured it will allow the pull to retract from the distal detachment tip (ddt) effectively detaching the embolization coil.Further evaluation revealed a fracture on the proximal end of the pusher assembly.This was likely a result of an incidental kink that also worsened to fracture.Evaluation of the returned lantern revealed an ovalized region on its distal tip.This damage may have been due to interacting with other devices while being navigated through difficulty anatomy.This damage may also have been due to forcefully gripping the device while introducing it into the parent catheter.This ovalized region likely contributed to the difficulty experienced advancing the two subject coils during the procedure and during functional testing.No other devices associated with this complaint were returned for evaluation.Penumbra coils and catheters 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.This report is associated with mfr report numbers: 3005168196-2018-01165, 3005168196-2018-01166.

Event Description

The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance a pc400 through the lantern, the physician experienced resistance and the pc400 was unable to advance; therefore it was removed.Next, the physician re-attempted to advance the same pc400; however, resistance was experienced again and, consequently, the pc400 pusher assembly became kinked; therefore, it was removed.The physician then attempted to advance a new pc400 through the lantern, however, the same resistance was experienced again.The physician therefore removed the pc400, the lantern, and the non-penumbra sheath.Upon removal, the physician noticed that the tip of the lantern was slightly damaged.Nest, the physician inserted a new catheter and a non-penumbra microcatheter into the target location and attempted to advance the same pc400.Despite experiencing resistance, the physician was able to successfully deploy and detach the pc400.The procedure was then completed using 10 additional coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pc400 was fractured approximately 127.0 cm from the proximal end.The pc400 was fractured approximately 5.0 cm from the proximal end.The embolization coil was detached within the introducer sheath and its proximal constraint sphere is intact.Conclusions: evaluation of the returned pc400 revealed the device was fractured.This damage was likely a result of the reported kink on the pusher assembly becoming fractured.The proximal kink was likely a result of the reported advancement of the pc400 against resistance.If a pc400 kink is further manipulated or otherwise mishandled, the kink may fatigue and fracture.Further evaluation revealed the embolization coil was detached and the pusher assembly fractured on the distal end.If the pusher assembly becomes fractured it will likely allow the pull wire to retract from the distal detachment tip (ddt), detaching the embolization coil.The distal fracture was incidental and likely occurred during handling post-procedure or when packaging for return to penumbra.Evaluation of the returned lantern revealed an ovalized region on its distal tip.This damage may have been due to interacting with other devices while being navigated through difficulty anatomy.This damage may also have been due to forcefully gripping the device while introducing it into the parent catheter.This ovalized region likely contributed to the difficulty experienced advancing the two subject coils during the procedure and during functional testing.No other devices associated with this complaint were returned for evaluation.Penumbra coils and catheters 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.This report is associated with mfr report numbers: 3005168196-2018-01165 and 3005168196-2018-01166.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7601344
• MDR Text Key: 111161307
• Report Number: 3005168196-2018-01164
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/15/2018

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
• Device Operator: Physician
• Device Catalogue Number: 4002C1040
• Device Lot Number: F73944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR