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

Catalog Number PNML6F088904M

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Results: a small piece was missing from the distal tip of the neuron max.The packaging mandrel was unsecured from its packaging tape.Conclusions: evaluation of the returned neuron max revealed a small piece of the distal tip was ripped off.If the packaging mandrel is unsecured from its packaging tape, it may slide into the packaging tube and pin the distal tip of the neuron max.If the device is retracted further, it is likely the distal tip will 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.

Event Description

During preparation for a medical procedure, upon removal of the neuron max 6f 088 long sheath (neuron max) from the packaging, the physician experienced resistance and subsequently a portion of the tip of neuron max 6f 088 long sheath was ripped off.The damage to the neuron max was found prior to use.Therefore, the neuron max was not used in the procedure.The procedure was completed using a new neuron max.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7491203
• MDR Text Key: 107506287
• Report Number: 3005168196-2018-00957
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

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
• Device Operator: Physician
• Device Expiration Date: 01/24/2021
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F81589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1