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	08/17/2018
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.This device is available for ret this report is associated with mfr report number: 3005168196-2018-01793.
Event or Problem Description
During preparation for a medical procedure, the hospital staff found that two neuron max 6f 088 long sheaths (neuron maxs) tip were ripped off while removing from their packagings.The damage to the neuron maxs were found prior to use.Therefore, the neuron maxs were not used in the procedure.The procedure was completed using a new neuron max.
Additional Manufacturer Narrative
Results: the neuron max had a damaged atraumatic tip.The packaging mandrel was unsecured from the packaging tape.The complaint did not involve device functionality; therefore, no functional analysis was performed.Conclusions: evaluation of the returned neuron maxs confirmed that the atraumatic tips were damaged for both devices.If the packaging mandrel becomes unsecured from the packaging tape during retraction of the catheter it may interact with the packaging tube.The distal tip of the neuron max may become pinned between the packaging mandrel and packaging tube.If the catheter is subsequently retracted while pinned, the tip 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: 7870501
• Report Number: 3005168196-2018-01794
• Device Sequence Number: 11221478
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018
• 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: 01/29/2021
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F81672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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