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

Catalog Number	PXSLIMLAN150T90
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2019-01031, 3005168196-2019-01032, 3005168196-2019-01033.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed a ruby coil using a lantern.The physician then felt resistance while advancing another ruby coil and, therefore, the ruby coil was removed.Upon removal, the physician reported that the coil was "stretched".The physician then switched to a new lantern and attempted to place a new ruby coil, however, the physician was unable to advance this ruby coil as well.Therefore, the ruby coil was removed, and the procedure ended at this point, despite the low packing density.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: 8640721
• Report Number: 3005168196-2019-01036
• Device Sequence Number: 11266873
• Product Code: DQY
• UDI-Device Identifier: 00814548016696
• UDI-Public: 00814548016696
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 04/25/2019
• 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 Catalogue Number: PXSLIMLAN150T90
• Was Device Available for Evaluation?: No
• 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: 04/25/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005