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

Catalog Number	PND6F070956
Medical Device Problem Codes	Physical Resistance (2578); Folded (2630)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 070 was repeatedly kinked approximately 94.0 thru 97.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the distal shaft of the neuron 070 was repeatedly kinked.This type of damage typically occurs due to improper handling during use.If the peel-able sheath is not used to protect the distal shaft of the catheter prior to advancement through another device, damage such as this may occur.The kinks in the distal shaft of the neuron 070 may have contributed to the reported resistance.The non-penumbra sheath referred to in the complaint was not returned for evaluation.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 thrombectomy procedure using a neuron delivery catheter 070 (neuron 070).During the procedure, the physician experienced resistance while advancing the neuron 070 to the target location after being advanced through a sheath, and therefore the neuron 070 was removed.Upon removal, the physician noticed that the tip of the neuron 070 had become kinked and had an "accordion affect".The procedure was therefore completed using a new neuron 070 and the same sheath.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: 7261660
• Report Number: 3005168196-2018-00308
• Device Sequence Number: 1176785
• Product Code: DQY
• UDI-Device Identifier: 00814548010069
• UDI-Public: 00814548010069
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/18/2018

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
• Operator of Device: Physician
• Device Expiration Date: 08/23/2020
• Device Catalogue Number: PND6F070956
• Device Lot Number: F78830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR