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

Catalog Number	PXSLIMLAN135T90
Medical Device Problem Codes	Physical Resistance (2578); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the lantern delivery microcatheter (lantern) was ovalized on its distal tip, approximately 134.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the distal tip was ovalized.This damage may have occurred due to forceful gripping or pinching of the lantern during insertion into the parent catheter, and likely contributed to the inability to advance the coils during the procedure.The coils mentioned in the complaint were not returned for evaluation.Penumbra 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance ruby coils through the lantern, the physician encountered resistance and was unable to advance the coils.Therefore, the devices were removed.It was reported that the tip of the lantern had become ovalized.Thereafter, the procedure was completed using a new lantern and the same ruby coils.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: 6615065
• Report Number: 3005168196-2017-00865
• Device Sequence Number: 16406312
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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: 07/13/2019
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F70582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1