MAUDE Adverse Event Report: PENUMBRA, INC. NEURON DELIVERY CATHETER 070; DQY

Catalog Number	PND6F0701058
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized approximately 101.0 and 110.0 cm from the hub (figure 2).The neuron 070 was partially fractured under the strain relief.Conclusions: evaluation of the returned neuron 070 revealed a partial fracture under the strain relief.The partial fracture is likely a result of forcefully manipulating the proximal end of the device at extreme angles.Further evaluation revealed ovalizations on the device.Based on the return condition and the reported complaint, the ovalization damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra catheters are visually 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 neuron delivery catheter 070 (neuron 070).During the procedure, the physician placed a neuron 070 in the patient¿s body and hooked up the flush; however, a small hole was noticed and the neuron 070 was leaking fluid.Therefore, it was removed.The procedure was completed using a new neuron 070.There was no report of an adverse effect to the patient.

• Brand Name: NEURON DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7857545
• Report Number: 3005168196-2018-01770
• Device Sequence Number: 11379866
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2018
• 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: 01/09/2021
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F81362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• 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: 08/13/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 53
• Date Report Sent to FDA: 01/01/2005