MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER; DQY

Catalog Number	PXSLIMLAN150T90
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2016-01543, 3005168196-2016-01545, 3005168196-2016-01546, 3005168196-2016-01547.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and lantern delivery microcatheters (lantern).During the procedure, while attempting to advance a ruby coil through a lantern, the physician experienced resistance and the ruby coil became stuck in the lantern.Therefore, the ruby coil and lantern were removed.The physician then placed a new lantern in the target vessel and attempted to advance a new ruby coil.While advancing the new ruby coil through the lantern, the ruby coil became stuck in the lantern and would not advance further.Therefore, the ruby coil was removed.The physician then attempted to advance two other ruby coils through the lantern; however both ruby coils became stuck in the lantern at the same point and the ruby coils were removed.The procedure was completed using an additional 16 coils with the same lantern.It should be noted that the physician maintained continuous flush through the rotating hemostasis valve (rhv).There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6073133
• Report Number: 3005168196-2016-01544
• Device Sequence Number: 18845797
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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: Physician
• Device Expiration Date: 10/20/2018
• Device Catalogue Number: PXSLIMLAN150T90
• Device Lot Number: F66801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 11/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR