MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that the tip of the neuron max 6f 088 long sheath (neuron max) was stuck to the packaging mandrel and while removing the neuron max, the tip of the neuron max broke off.The damage to the neuron max occurred prior to use and, therefore, the neuron max was not used in the procedure.The procedure was completed using another neuron max.
Additional Manufacturer Narrative
Results: the returned device was damaged at the distal tip.The packaging mandrel had shifted underneath the packaging tape.Conclusions: evaluation of the returned neuron max revealed that the catheter was damaged at the distal tip.Further investigation revealed that the packaging mandrel was loose from the packaging tape.If the packaging mandrel is loose from the packaging tape, the tip of the catheter may become pinned between the packaging mandrel and the packaging tub.If the catheter is forcefully retracted while pinned, the tip of the catheter may become damaged.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.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8138912
• Report Number: 3005168196-2018-02377
• Device Sequence Number: 13847893
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018
• 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: 11/01/2020
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F80322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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